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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/NCT05093933
Registration number
NCT05093933
Ethics application status
Date submitted
18/10/2021
Date registered
26/10/2021
Date last updated
14/02/2024
Titles & IDs
Public title
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
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Scientific title
A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction
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Secondary ID [1]
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MK-1242-035
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Secondary ID [2]
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1242-035
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Universal Trial Number (UTN)
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Trial acronym
VICTOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure With Reduced Ejection Fraction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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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 - Vericiguat
Treatment: Drugs - Placebo
Experimental: Vericiguat - Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily. The vericiguat dose will be titrated to 5 mg and to 10 mg.
Placebo Comparator: Placebo - Participants receive a starting matching placebo to vericiguat dose of 2.5 mg taken orally once daily. The matching placebo dose will be sham titrated to 5 mg and to 10 mg.
Treatment: Drugs: Vericiguat
2.5, 5.0, or 10.0 mg orally once daily
Treatment: Drugs: Placebo
0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat
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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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Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
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Assessment method [1]
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The first event of CV death or HF hospitalization as confirmed by a clinical events committee (CEC).
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Timepoint [1]
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From date of randomization until the date of first occurrence of a CV death or HF hospitalization, assessed up to approximately 40 months
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Secondary outcome [1]
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Time to First Occurrence of CV Death
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Assessment method [1]
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The first event of CV death as confirmed by a CEC.
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Timepoint [1]
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From date of randomization until the date of first occurrence of a CV death, assessed up to approximately 40 months
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Secondary outcome [2]
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Time to First Occurrence of HF Hospitalization
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Assessment method [2]
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The first event of HF hospitalization as confirmed by a CEC.
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Timepoint [2]
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From date of randomization until the date of first occurrence of a HF hospitalization, assessed up to approximately 40 months
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Secondary outcome [3]
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Time to Total HF Hospitalizations (Including First and Recurrent Events)
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Assessment method [3]
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All events of HF hospitalization as confirmed by a CEC.
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Timepoint [3]
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Up to approximately 40 months
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Secondary outcome [4]
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Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization
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Assessment method [4]
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The first event of death due to any cause or HF hospitalization as confirmed by a CEC.
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Timepoint [4]
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From date of randomization until the date of first occurrence of death or HF hospitalization, assessed up to approximately 40 months
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Secondary outcome [5]
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Time to All-Cause Mortality
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Assessment method [5]
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The first event of death due to any cause as confirmed by a CEC.
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Timepoint [5]
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From date of randomization until the date of death, assessed up to approximately 40 months
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Secondary outcome [6]
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Percentage of Participants who Experienced One or More Selected Nonserious Adverse Events (NSAEs)
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Assessment method [6]
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Selected NSAEs are nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or coronavirus disease (COVID-19) disease-related AEs.
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Timepoint [6]
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Up to approximately 40 months
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Secondary outcome [7]
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Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)
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Assessment method [7]
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An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event, as judged medically or scientifically, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed above.
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Timepoint [7]
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Up to approximately 40 months
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Secondary outcome [8]
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Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)
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Assessment method [8]
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Events of clinical interest will include: 1) Potential drug-induced liver injury (DILI) events defined as: elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, as determined by way of protocol specified laboratory testing or unscheduled laboratory testing, 2) Symptomatic hypotension 3) Anemia.
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Timepoint [8]
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Up to approximately 40 months
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Eligibility
Key inclusion criteria
- History of chronic HF [New York Heart Association (NYHA) Class II to IV] on
guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization
within 6 months or outpatient IV diuretic use within 3 months before randomization.
- Left ventricular ejection fraction (LVEF) of =40%, assessed within 12 months before
randomization by any imaging method.
- Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
- A female participant is eligible to participate if she is not pregnant or
breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and
agrees to follow contraceptive guidance during the study intervention period and for
at least 1 month after the last dose of study intervention.
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Minimum age
18
Years
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Maximum age
No limit
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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
- Has SBP <100 mm Hg or symptomatic hypotension.
- Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or
has or anticipates receiving an implanted ventricular assist device.
- Amyloidosis or sarcoidosis.
- Primary valvular heart disease requiring surgical procedure or intervention or has
undergone a valvular surgical procedure or intervention within 3 months before
randomization.
- Hypertrophic cardiomyopathy.
- Acute myocarditis or Takotsubo cardiomyopathy.
- History of heart transplant.
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.
- Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or
percutaneous coronary intervention (PCI) within 3 months before randomization.
- History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke
within 3 months before randomization.
- Malignancy or other noncardiac condition limiting life expectancy to <3 years.
- Requires continuous home oxygen for severe pulmonary disease.
- Interstitial lung disease.
- Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before
randomization.
- Recent history (within the last year) of drug or alcohol abuse or dependence.
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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 3
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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
2/11/2021
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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
15/06/2025
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Actual
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Sample size
Target
6000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital-Cardiology Research ( Site 0453) - Brisbane
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Recruitment hospital [2]
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The Prince Charles Hospital-Cardiology Research Centre ( Site 0451) - Brisbane
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Core Research Group ( Site 0452) - Brisbane
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Royal Adelaide Hospital-Cardiology ( Site 0456) - Adelaide
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Flinders Medical Centre-Cardiology Research ( Site 0455) - Bedford Park
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Recruitment hospital [6]
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St. John of God Subiaco Hospital ( Site 0457) - Subiaco
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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4032 - Brisbane
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Recruitment postcode(s) [3]
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4064 - Brisbane
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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5042 - Bedford Park
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Recruitment postcode(s) [6]
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6008 - Subiaco
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Recruitment outside Australia
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0
0
Mecklenburg-Vorpommern
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Niedersachsen
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Nordrhein-Westfalen
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Rheinland-Pfalz
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Sachsen
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Thuringen
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Berlin
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Hamburg
Query!
Country [115]
0
0
Greece
Query!
State/province [115]
0
0
Attiki
Query!
Country [116]
0
0
Greece
Query!
State/province [116]
0
0
Dytiki Ellada
Query!
Country [117]
0
0
Greece
Query!
State/province [117]
0
0
Evros
Query!
Country [118]
0
0
Greece
Query!
State/province [118]
0
0
Thessalia
Query!
Country [119]
0
0
Greece
Query!
State/province [119]
0
0
Thessaloniki
Query!
Country [120]
0
0
Guatemala
Query!
State/province [120]
0
0
Guatemala City
Query!
Country [121]
0
0
Guatemala
Query!
State/province [121]
0
0
Guatemala
Query!
Country [122]
0
0
Hong Kong
Query!
State/province [122]
0
0
Aberdeen
Query!
Country [123]
0
0
Hong Kong
Query!
State/province [123]
0
0
Hksar
Query!
Country [124]
0
0
Hong Kong
Query!
State/province [124]
0
0
Hong Kong
Query!
Country [125]
0
0
Hong Kong
Query!
State/province [125]
0
0
Shatin
Query!
Country [126]
0
0
Hungary
Query!
State/province [126]
0
0
Bacs-Kiskun
Query!
Country [127]
0
0
Hungary
Query!
State/province [127]
0
0
Baranya
Query!
Country [128]
0
0
Hungary
Query!
State/province [128]
0
0
Bekes
Query!
Country [129]
0
0
Hungary
Query!
State/province [129]
0
0
Csongrad
Query!
Country [130]
0
0
Hungary
Query!
State/province [130]
0
0
Gyor-Moson-Sopron
Query!
Country [131]
0
0
Hungary
Query!
State/province [131]
0
0
Pest
Query!
Country [132]
0
0
Hungary
Query!
State/province [132]
0
0
Szekesfehervar
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
Szekszard
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Veszprem
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Budapest
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Nyiregyhaza
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Zalaegerszeg
Query!
Country [138]
0
0
Ireland
Query!
State/province [138]
0
0
Dublin
Query!
Country [139]
0
0
Israel
Query!
State/province [139]
0
0
Ashdod
Query!
Country [140]
0
0
Israel
Query!
State/province [140]
0
0
Hadera
Query!
Country [141]
0
0
Israel
Query!
State/province [141]
0
0
Haifa
Query!
Country [142]
0
0
Israel
Query!
State/province [142]
0
0
Jerusalem
Query!
Country [143]
0
0
Israel
Query!
State/province [143]
0
0
Nahariya
Query!
Country [144]
0
0
Israel
Query!
State/province [144]
0
0
Petah-Tikva
Query!
Country [145]
0
0
Israel
Query!
State/province [145]
0
0
Ramat Gan
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Rehovot
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Zerifin
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Emilia-Romagna
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Friuli-Venezia Giulia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Lazio
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Lombardia
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Milano
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Roma
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Toscana
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Bergamo
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Bologna
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Brescia
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Pavia
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Perugia
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Torino
Query!
Country [161]
0
0
Korea, Republic of
Query!
State/province [161]
0
0
Chungbuk
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Incheon
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Kang-won-do
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Kwangju-Kwangyokshi
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Kyonggi-do
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Pusan-Kwangyokshi
Query!
Country [167]
0
0
Korea, Republic of
Query!
State/province [167]
0
0
Taejon-Kwangyokshi
Query!
Country [168]
0
0
Korea, Republic of
Query!
State/province [168]
0
0
Seoul
Query!
Country [169]
0
0
Malaysia
Query!
State/province [169]
0
0
Kedah
Query!
Country [170]
0
0
Malaysia
Query!
State/province [170]
0
0
Kelantan
Query!
Country [171]
0
0
Malaysia
Query!
State/province [171]
0
0
Kuala Lumpur
Query!
Country [172]
0
0
Malaysia
Query!
State/province [172]
0
0
Pahang
Query!
Country [173]
0
0
Malaysia
Query!
State/province [173]
0
0
Sabah
Query!
Country [174]
0
0
Malaysia
Query!
State/province [174]
0
0
Sarawak
Query!
Country [175]
0
0
Malaysia
Query!
State/province [175]
0
0
Selangor
Query!
Country [176]
0
0
Malaysia
Query!
State/province [176]
0
0
Terengganu
Query!
Country [177]
0
0
Mexico
Query!
State/province [177]
0
0
Baja California
Query!
Country [178]
0
0
Mexico
Query!
State/province [178]
0
0
Chihuahua
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Coahuila
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
Distrito Federal
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
Guerrero
Query!
Country [182]
0
0
Mexico
Query!
State/province [182]
0
0
Hidalgo
Query!
Country [183]
0
0
Mexico
Query!
State/province [183]
0
0
Jalisco
Query!
Country [184]
0
0
Mexico
Query!
State/province [184]
0
0
Nuevo Leon
Query!
Country [185]
0
0
Mexico
Query!
State/province [185]
0
0
San Luis Potosi
Query!
Country [186]
0
0
Mexico
Query!
State/province [186]
0
0
Sinaloa
Query!
Country [187]
0
0
Mexico
Query!
State/province [187]
0
0
Tamaulipas
Query!
Country [188]
0
0
Mexico
Query!
State/province [188]
0
0
Veracruz
Query!
Country [189]
0
0
Mexico
Query!
State/province [189]
0
0
Yucatan
Query!
Country [190]
0
0
Mexico
Query!
State/province [190]
0
0
Aguascalientes
Query!
Country [191]
0
0
Mexico
Query!
State/province [191]
0
0
Oaxaca
Query!
Country [192]
0
0
New Zealand
Query!
State/province [192]
0
0
Canterbury
Query!
Country [193]
0
0
New Zealand
Query!
State/province [193]
0
0
Otago
Query!
Country [194]
0
0
New Zealand
Query!
State/province [194]
0
0
Waikato
Query!
Country [195]
0
0
New Zealand
Query!
State/province [195]
0
0
Wellington
Query!
Country [196]
0
0
New Zealand
Query!
State/province [196]
0
0
Auckland
Query!
Country [197]
0
0
Peru
Query!
State/province [197]
0
0
La Libertad
Query!
Country [198]
0
0
Peru
Query!
State/province [198]
0
0
Lima
Query!
Country [199]
0
0
Peru
Query!
State/province [199]
0
0
Qallaw
Query!
Country [200]
0
0
Peru
Query!
State/province [200]
0
0
Piura
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Dolnoslaskie
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Kujawsko-pomorskie
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Lubelskie
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Malopolskie
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Mazowieckie
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Opolskie
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Podkarpackie
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Podlaskie
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Pomorskie
Query!
Country [210]
0
0
Puerto Rico
Query!
State/province [210]
0
0
Bayamon
Query!
Country [211]
0
0
Puerto Rico
Query!
State/province [211]
0
0
Humacao
Query!
Country [212]
0
0
Puerto Rico
Query!
State/province [212]
0
0
Ponce
Query!
Country [213]
0
0
Puerto Rico
Query!
State/province [213]
0
0
Rio Grande
Query!
Country [214]
0
0
Puerto Rico
Query!
State/province [214]
0
0
San Juan
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Ivanovskaya Oblast
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Krasnodarskiy Kray
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Leningradskaya Oblast
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Moskva
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Omskaya Oblast
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Permskiy Kray
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Rostovskaya Oblast
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Ryazanskaya Oblast
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Sankt-Peterburg
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Saratovskaya Oblast
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Tatarstan, Respublika
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Volgogradskaya Oblast
Query!
Country [227]
0
0
Singapore
Query!
State/province [227]
0
0
Central Singapore
Query!
Country [228]
0
0
Singapore
Query!
State/province [228]
0
0
South East
Query!
Country [229]
0
0
Singapore
Query!
State/province [229]
0
0
South West
Query!
Country [230]
0
0
South Africa
Query!
State/province [230]
0
0
Free State
Query!
Country [231]
0
0
South Africa
Query!
State/province [231]
0
0
Gauteng
Query!
Country [232]
0
0
South Africa
Query!
State/province [232]
0
0
Kwazulu-Natal
Query!
Country [233]
0
0
South Africa
Query!
State/province [233]
0
0
Western Cape
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Barcelona
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Cataluna
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
La Coruna
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Madrid, Comunidad De
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Valenciana, Comunitat
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Madrid
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Sevilla
Query!
Country [241]
0
0
Sweden
Query!
State/province [241]
0
0
Dalarnas Lan
Query!
Country [242]
0
0
Sweden
Query!
State/province [242]
0
0
Orebro Lan
Query!
Country [243]
0
0
Sweden
Query!
State/province [243]
0
0
Skane Lan
Query!
Country [244]
0
0
Sweden
Query!
State/province [244]
0
0
Stockholms Lan
Query!
Country [245]
0
0
Sweden
Query!
State/province [245]
0
0
Vasterbottens Lan
Query!
Country [246]
0
0
Sweden
Query!
State/province [246]
0
0
Vastmanlands Lan
Query!
Country [247]
0
0
Sweden
Query!
State/province [247]
0
0
Vastra Gotalands Lan
Query!
Country [248]
0
0
Taiwan
Query!
State/province [248]
0
0
Changhua
Query!
Country [249]
0
0
Taiwan
Query!
State/province [249]
0
0
Hsinchu
Query!
Country [250]
0
0
Taiwan
Query!
State/province [250]
0
0
Kaohsiung
Query!
Country [251]
0
0
Taiwan
Query!
State/province [251]
0
0
Taichung
Query!
Country [252]
0
0
Taiwan
Query!
State/province [252]
0
0
Taipei
Query!
Country [253]
0
0
Taiwan
Query!
State/province [253]
0
0
Taoyuan
Query!
Country [254]
0
0
Turkey
Query!
State/province [254]
0
0
Izmir
Query!
Country [255]
0
0
Turkey
Query!
State/province [255]
0
0
Afyonkarahisar
Query!
Country [256]
0
0
Turkey
Query!
State/province [256]
0
0
Ankara
Query!
Country [257]
0
0
Turkey
Query!
State/province [257]
0
0
Antalya
Query!
Country [258]
0
0
Turkey
Query!
State/province [258]
0
0
Eskisehir
Query!
Country [259]
0
0
Turkey
Query!
State/province [259]
0
0
Istanbul
Query!
Country [260]
0
0
Turkey
Query!
State/province [260]
0
0
Kocaeli
Query!
Country [261]
0
0
Turkey
Query!
State/province [261]
0
0
Mersin
Query!
Country [262]
0
0
Ukraine
Query!
State/province [262]
0
0
Cherkaska Oblast
Query!
Country [263]
0
0
Ukraine
Query!
State/province [263]
0
0
Ivano-Frankivska Oblast
Query!
Country [264]
0
0
Ukraine
Query!
State/province [264]
0
0
Kharkivska Oblast
Query!
Country [265]
0
0
Ukraine
Query!
State/province [265]
0
0
Khmelnytska Oblast
Query!
Country [266]
0
0
Ukraine
Query!
State/province [266]
0
0
Kyivska Oblast
Query!
Country [267]
0
0
Ukraine
Query!
State/province [267]
0
0
Kyiv
Query!
Country [268]
0
0
Ukraine
Query!
State/province [268]
0
0
Odeska Oblast
Query!
Country [269]
0
0
Ukraine
Query!
State/province [269]
0
0
Vinnytska Oblast
Query!
Country [270]
0
0
Ukraine
Query!
State/province [270]
0
0
Volynska Oblast
Query!
Country [271]
0
0
Ukraine
Query!
State/province [271]
0
0
Zakarpatska Oblast
Query!
Country [272]
0
0
Ukraine
Query!
State/province [272]
0
0
Zaporizka Oblast
Query!
Country [273]
0
0
Ukraine
Query!
State/province [273]
0
0
Zhytomyrska Oblast
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
Cumbria
Query!
Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
Derbyshire
Query!
Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Dundee City
Query!
Country [277]
0
0
United Kingdom
Query!
State/province [277]
0
0
England
Query!
Country [278]
0
0
United Kingdom
Query!
State/province [278]
0
0
Great Britain
Query!
Country [279]
0
0
United Kingdom
Query!
State/province [279]
0
0
Lancashire
Query!
Country [280]
0
0
United Kingdom
Query!
State/province [280]
0
0
Lisburn And Castlereagh
Query!
Country [281]
0
0
United Kingdom
Query!
State/province [281]
0
0
London, City Of
Query!
Country [282]
0
0
United Kingdom
Query!
State/province [282]
0
0
Northern Ireland
Query!
Country [283]
0
0
United Kingdom
Query!
State/province [283]
0
0
Wales
Query!
Country [284]
0
0
United Kingdom
Query!
State/province [284]
0
0
Walsall
Query!
Country [285]
0
0
United Kingdom
Query!
State/province [285]
0
0
Worcestershire
Query!
Country [286]
0
0
United Kingdom
Query!
State/province [286]
0
0
Blackpool
Query!
Country [287]
0
0
United Kingdom
Query!
State/province [287]
0
0
Coventry
Query!
Country [288]
0
0
United Kingdom
Query!
State/province [288]
0
0
Poole
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United Kingdom
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Stockton-On-Tees
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of vericiguat in
participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically
those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart
failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that
vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart
failure hospitalization.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05093933
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05093933
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