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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01065454
Registration number
NCT01065454
Ethics application status
Date submitted
8/02/2010
Date registered
9/02/2010
Date last updated
16/05/2024
Titles & IDs
Public title
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
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Scientific title
Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-center Study to Evaluate the Hemodynamic Effects of Riociguat (BAY 63-2521) as Well as Safety and Kinetics in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
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Secondary ID [1]
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2023-507001-34-00
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Secondary ID [2]
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14308
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Universal Trial Number (UTN)
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Trial acronym
LEPHT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary
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Ventricular Dysfunction, Left
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Riociguat (Adempas, BAY63-2521)
Treatment: Drugs - Placebo
Experimental: Riociguat (Adempas, BAY63-2521) up to 2 mg - Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
Experimental: Riociguat (Adempas, BAY63-2521) up to 1 mg - Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
Experimental: Riociguat (Adempas, BAY63-2521) fixed 0.5 mg - Participants received riociguat 0.5 mg tid (fixed dose).
Placebo Comparator: Placebo - Participants received placebo tid.
Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
up to 2 mg three times a day (increasing from 0.5 to 1 to 2 mg)
Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
up to 1 mg three times a day (increasing from 0.5 to 1 mg)
Treatment: Drugs: Riociguat (Adempas, BAY63-2521)
fixed 0.5 mg three times a day
Treatment: Drugs: Placebo
Placebo three times a day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pulmonary Artery Mean Pressure (PAPmean) at Rest - Change From Baseline to Week 16
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Assessment method [1]
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Mean pulmonary arterial pressure (PAPmean) is a directly measured hemodynamic parameter. PAPmean is recorded during a right heart catheterization.
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Timepoint [1]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [1]
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Venous Oxygen Saturation (SvO2) - Change From Baseline to Week 16
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Assessment method [1]
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The mixed venous oxygen saturation rate (SvO2) is a directly measured hemodynamic parameter. SvO2 is recorded during a right heart catheterization.
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Timepoint [1]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [2]
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Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 16
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Assessment method [2]
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The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80*(PAPmean - PCWP)/CO
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Timepoint [2]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [3]
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Pulmonary Vascular Resistance Index (PVRi) - Change From Baseline to Week 16
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Assessment method [3]
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The pulmonary vascular resistance index (PVRi) is a calculated hemodynamic parameter. PVRi is derived from the pulmonary vascular resistance (PVR) normalized by the body surface area (BSA). Formula: PVRi = 80*(PAPmean - PCWP)*BSA/CO
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Timepoint [3]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [4]
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Systemic Vascular Resistance (SVR) - Change From Baseline to Week 16
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Assessment method [4]
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The systemic vascular resistance (SVR) is a calculated hemodynamic parameter. SVR is derived from the directly measured parameter mean right atrial pressure (RAPmean) and the calculated parameter mean systemic arterial pressure (SAPmean) divided by the cardiac output (CO). RAPmean is acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: SVR = 80*(SAPmean - RAPmean)/CO
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Timepoint [4]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [5]
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Systemic Vascular Resistance Index (SVRi) - Change From Baseline to Week 16
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Assessment method [5]
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The systemic vascular resistance index (SVRi) is a calculated hemodynamic parameter. SVRi is derived from the systemic vascular resistance (SVR) normalized by the body surface area (BSA). Formula: SVRi = 80*(SAPmean - RAPmean)*BSA/CO
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Timepoint [5]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [6]
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Transpulmonary Pressure Gradient (TPG) - Change From Baseline to Week 16
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Assessment method [6]
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The transpulmonary pressure gradient (TPG) is a calculated hemodynamic parameter. TPG is calculated from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP). These 2 parameters are acquired during a right heart catheterization. Formula: TPG = PAPmean - PCWP
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Timepoint [6]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [7]
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Pulmonary Capillary Wedge Pressure (PCWP) - Change From Baseline to Week 16
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Assessment method [7]
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Pulmonary capillary wedge pressure (PCWP) is a directly measured hemodynamic parameter acquired during a right heart catheterization.
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Timepoint [7]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [8]
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Tricuspid Annular Plane Systolic Excursion (TAPSE) - Change From Baseline to Week 16
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Assessment method [8]
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The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
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Timepoint [8]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [9]
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Systolic Pulmonary Arterial Pressure (PAPsyst) - Change From Baseline to Week 16
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Assessment method [9]
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Systolic pulmonary arterial pressure (PAPsyst) is a directly measured hemodynamic parameter acquired during a right heart catheterization.
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Timepoint [9]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [10]
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Left Ventricular Ejection Fraction (LVEF) - Change From Baseline to Week 16
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Assessment method [10]
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The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100*(LVEDV - LVESV)/LVEDV
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Timepoint [10]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [11]
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Left Ventricular End-systolic Volume (LVESV) - Change From Baseline to Week 16
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Assessment method [11]
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Left ventricular end-systolic volume (LVESV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
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Timepoint [11]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [12]
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Left Ventricular End-diastolic Volume (LVEDV) - Change From Baseline to Week 16
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Assessment method [12]
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Left ventricular end-diastolic volume (LVEDV) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
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Timepoint [12]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [13]
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E-wave Deceleration Time - Change From Baseline to Week 16
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Assessment method [13]
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E-wave deceleration time is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.
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Timepoint [13]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [14]
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Ratio of Mitral Peak Velocity of Early Filling to Mitral Peak Velocity of Late Filling (E/A) - Change From Baseline to Week 16
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Assessment method [14]
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E/A ratio is a measured echocardiography parameter and describes the ratio of mitral peak velocity of early filling to mitral peak velocity of late filling. It is acquired during a non-invasive echocardiography examination.
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Timepoint [14]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [15]
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6-minute Walking Distance (6MWD) - Change From Baseline to Week 16
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Assessment method [15]
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6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.
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Timepoint [15]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [16]
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WHO (World Health Organization) Functional Class - Change From Baseline to Week 16
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Assessment method [16]
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The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (Patients with PH but without resulting limitation of physical activity) to class IV (Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement, changes to a higher functional class resemble deterioration of PAH.
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Timepoint [16]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [17]
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Percentage of Participants With Clinical Worsening
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Assessment method [17]
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The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all cause mortality, including cardiovascular mortality; first hospitalization for a cardiovascular event, including heart failure, acute myocardial infarction, stroke or ventricular arrhythmia; upgrade of the HTx (heart transplantation) status to next higher level; need for IV diuretics; persistent worsening of WHO functional class due to deterioration of PH or cardiac function.
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Timepoint [17]
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At visit 6 (16 weeks)
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Secondary outcome [18]
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Borg CR 10 Scale - Change From Baseline to Week 16
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Assessment method [18]
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The Borg CR10 Scale is a patient reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the patient's exertion during a physical test. Low values indicate low levels of exertion, high values indicate more intense exertion reported by the patient. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").
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Timepoint [18]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [19]
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EQ-5D Utility Score - Change From Baseline to Week 16
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Assessment method [19]
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EQ-5D utility score is a Quality-of-Life patient reported outcome measure. An increase in the utility score represents an improvement in quality of life. The score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
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Timepoint [19]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [20]
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Minnesota Living With Heart Failure Questionnaire (MLHF) Score - Change From Baseline to Week 16
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Assessment method [20]
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The self-reported Minnesota Living with Heart Failure questionnaire (MLHF) is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The MLHF total score can range from 0 (best) to 105 (worst).
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Timepoint [20]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [21]
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Cystatin C - Change From Baseline to Week 16
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Assessment method [21]
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Cystatin C is a biomarker for predicting new onset or deteriorating cardiovascular disease.
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Timepoint [21]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [22]
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N-terminal Pro-brain Natriuretic Peptide (NT-pro BNP) - Change From Baseline to Week 16
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Assessment method [22]
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N-terminal pro-brain natriuretic peptide (NT-pro BNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.
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Timepoint [22]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [23]
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Troponin T - Change From Baseline to Week 16
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Assessment method [23]
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Troponin T is a cardiac-specific protein which is released from damaged or injured heart muscle cells.
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Timepoint [23]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [24]
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Asymmetric Dimethylarginine (ADMA) - Change From Baseline to Week 16
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Assessment method [24]
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Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxides. Recent clinical studies have indicated that ADMA may have diagnostic relevance as a novel cardiovascular risk marker.
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Timepoint [24]
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Baseline and visit 6 (16 weeks)
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Secondary outcome [25]
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Osteopontin - Change From Baseline to Week 16
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Assessment method [25]
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Osteopontin is a cytokine-like pro-fibrotic mediator, which is expressed in cardiovascular tissues. Its expression is induced by increased pressure and volume load in the myocardium, kidney and lung. Therefore, osteopontin may be used as a prognostic marker in patients with cardiovascular diseases.
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Timepoint [25]
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Baseline and visit 6 (16 weeks)
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Eligibility
Key inclusion criteria
- Male and female patients with symptomatic pulmonary hypertension due to left
ventricular systolic dysfunction despite optimized heart failure therapy
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Types of pulmonary hypertension other than group 2.1 of Dana Point Classification
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/04/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
202
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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- Darlinghurst
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Recruitment hospital [2]
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- Chermside
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Recruitment hospital [3]
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- Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Iowa
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Country [4]
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United States of America
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State/province [4]
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Maryland
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Country [5]
0
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Minnesota
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Country [7]
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United States of America
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State/province [7]
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Missouri
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Country [8]
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United States of America
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State/province [8]
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Ohio
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Country [9]
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United States of America
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State/province [9]
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Virginia
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Country [10]
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United States of America
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State/province [10]
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Wisconsin
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Country [11]
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Austria
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State/province [11]
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Tirol
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Country [12]
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Austria
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State/province [12]
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Wien
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Country [13]
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Belgium
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State/province [13]
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Aalst
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Country [14]
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Belgium
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State/province [14]
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Bruxelles - Brussel
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Country [15]
0
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Belgium
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State/province [15]
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Gent
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Country [16]
0
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Belgium
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State/province [16]
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Leuven
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Country [17]
0
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Canada
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State/province [17]
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Alberta
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Country [18]
0
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Canada
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State/province [18]
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British Columbia
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Country [19]
0
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Canada
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State/province [19]
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Quebec
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Country [20]
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China
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State/province [20]
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Beijing
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Country [21]
0
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China
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State/province [21]
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Shanghai
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Country [22]
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Czechia
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State/province [22]
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Brno
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Country [23]
0
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Czechia
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State/province [23]
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Olomouc
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Country [24]
0
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Czechia
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State/province [24]
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Praha 2
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Country [25]
0
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Czechia
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State/province [25]
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Praha 4
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Country [26]
0
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Denmark
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State/province [26]
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Aarhus N
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Country [27]
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France
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State/province [27]
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Bron
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Country [28]
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France
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State/province [28]
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Lille Cedex
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Country [29]
0
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France
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State/province [29]
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Nantes
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Country [30]
0
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France
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State/province [30]
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Pessac
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Country [31]
0
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France
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State/province [31]
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Rouen
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Country [32]
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France
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State/province [32]
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Toulouse
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Country [33]
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Germany
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State/province [33]
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Baden-Württemberg
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Country [34]
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Germany
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State/province [34]
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Bayern
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Country [35]
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Germany
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State/province [35]
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Mecklenburg-Vorpommern
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Country [36]
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Germany
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State/province [36]
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Nordrhein-Westfalen
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Country [37]
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Germany
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State/province [37]
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Thüringen
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Country [38]
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Italy
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State/province [38]
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Campania
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Country [39]
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Italy
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State/province [39]
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Lombardia
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Country [40]
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Japan
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State/province [40]
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Aichi
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Country [41]
0
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Japan
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State/province [41]
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Gifu
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Country [42]
0
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Japan
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State/province [42]
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0
Ibaraki
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Country [43]
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Japan
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State/province [43]
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Mie
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Country [44]
0
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Japan
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State/province [44]
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Miyagi
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Country [45]
0
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Japan
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State/province [45]
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Osaka
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Country [46]
0
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Japan
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State/province [46]
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Shiga
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Country [47]
0
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Japan
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State/province [47]
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Shizuoka
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Country [48]
0
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Japan
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State/province [48]
0
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Tokyo
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Country [49]
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Japan
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State/province [49]
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0
Wakayama
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Country [50]
0
0
Netherlands
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State/province [50]
0
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Amsterdam
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Country [51]
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Netherlands
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State/province [51]
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Nijmegen
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Country [52]
0
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Poland
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State/province [52]
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Bydgoszcz
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Country [53]
0
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Poland
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State/province [53]
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Gdansk
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Country [54]
0
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Poland
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State/province [54]
0
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Warszawa
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Country [55]
0
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Singapore
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State/province [55]
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Singapore
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Country [56]
0
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Spain
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State/province [56]
0
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Madrid
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Country [57]
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Spain
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State/province [57]
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Murcia
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Country [58]
0
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Spain
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State/province [58]
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Palma De Mallorca
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Country [59]
0
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Spain
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State/province [59]
0
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A Coruña
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Country [60]
0
0
Spain
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State/province [60]
0
0
Barcelona
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Country [61]
0
0
Spain
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State/province [61]
0
0
Valencia
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Country [62]
0
0
Switzerland
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State/province [62]
0
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Genève
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Country [63]
0
0
Switzerland
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State/province [63]
0
0
Ticino
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Country [64]
0
0
Switzerland
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State/province [64]
0
0
Zürich
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Country [65]
0
0
United Kingdom
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State/province [65]
0
0
Cambridge
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Country [66]
0
0
United Kingdom
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State/province [66]
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0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The aim of this study is to assess whether increasing oral doses of Riociguat are safe and
improve the well-being, symptoms and outcome in patients with pulmonary hypertension
associated with left ventricular systolic dysfunction
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01065454
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Public notes
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Contacts
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Bayer Study Director
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Bayer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01065454
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