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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/NCT01870778




Registration number
NCT01870778
Ethics application status
Date submitted
3/06/2013
Date registered
6/06/2013
Date last updated
30/03/2018

Titles & IDs
Public title
Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients
Secondary ID [1] 0 0
2013-001498-25
Secondary ID [2] 0 0
CRLX030A2301
Universal Trial Number (UTN)
Trial acronym
RELAX-AHF-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RLX030
Treatment: Drugs - Placebo

Experimental: Serelaxin (RLX030) - Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.

Placebo Comparator: Placebo - Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.


Treatment: Drugs: RLX030
1 mg/mL solution in 6 mL vials

Treatment: Drugs: Placebo
Matching placebo solution to serelaxin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180
Timepoint [1] 0 0
180 days
Primary outcome [2] 0 0
Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5
Timepoint [2] 0 0
Day 5
Secondary outcome [1] 0 0
Percentage of Participants With All-cause Death Through Day 180
Timepoint [1] 0 0
180 days
Secondary outcome [2] 0 0
Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization
Timepoint [2] 0 0
180 days (Participants still in the hospital at Day 60 were censored at Day 60)
Secondary outcome [3] 0 0
Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
Timepoint [4] 0 0
180 days (Patients still in the hospital at Day 60 were censored at Day 60)
Secondary outcome [5] 0 0
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
Timepoint [5] 0 0
From baseline to Day 5
Secondary outcome [6] 0 0
Change From Baseline in hsTroponin T Biomarker
Timepoint [6] 0 0
Baseline, Day 2, Day 5 and Day 14
Secondary outcome [7] 0 0
Change From Baseline in NT-proBNP Biomarker
Timepoint [7] 0 0
Baseline, Day 2, Day 5 and Day 14
Secondary outcome [8] 0 0
Change From Baseline in Cystatin C Biomarker
Timepoint [8] 0 0
Baseline, Day 2, Day 5 and Day 14

Eligibility
Key inclusion criteria
Key

- Male or female 18 years of age, with body weight =160 kg

- Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours;
AHF is defined as including all of the following measured at any time between
presentation (including the emergency department) and the end of screening:

- Persistent dyspnea at rest or with minimal exertion

- Pulmonary congestion on chest radiograph

- B-type natriuretic peptide (BNP) =500 pg/mL or N-terminal (NT)-proBNP =2000
pg/mL; for patients = 75 years of age or with current atrial fibrillation (at the
time of randomization), BNP = 750 pg/mL or NT-proBNP = 3,000 pg/mL

- Systolic BP =125 mmHg at the start and at the end of screening

- Able to be randomized within 16 hours from presentation to the hospital, including the
emergency department

- Received intravenous furosemide of at least 40 mg total (or equivalent) at any time
between presentation (this includes outpatient clinic, ambulance, or hospital
including emergency department) and the start of screening for the study for the
treatment of the current acute HF episode.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Dyspnea primarily due to non-cardiac causes

- Known history of respiratory disorders requiring the daily use of IV or oral steroids
(does not include inhaled steroids); need for intubation or the current use of IV or
oral steroids for chronic obstructive pulmonary disease (COPD)

- Temperature >38.5°C (oral or equivalent) or sepsis or active infection requiring IV
anti-microbial treatment

- Clinical evidence of acute coronary syndrome currently or within 30 days prior to
enrollment.

- AHF due to significant arrhythmias, which include any of the following: sustained
ventricular tachycardia, bradycardia with sustained ventricular rate <45 beats per
minute, or atrial fibrillation/flutter with sustained ventricular response of >130
beats per minute

- Patients with severe renal impairment defined as pre-randomization estimated
glomerular filtration rate (eGFR) < 25 mL/min/1.73m2 calculated using the Simplified
Modification of Diet in Renal Disease (sMDRD) equation, and/or those receiving current
or planned dialysis or ultrafiltration

- Patients with hematocrit <25%, or a history of blood transfusion within the 14 days
prior to screening, or active life-threatening GI bleeding.

- Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased
ammonia levels, if performed) or history of cirrhosis with evidence of portal
hypertension such as varices.

- Significant, uncorrected, left ventricular outflow obstruction, such as obstructive
hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0
cm2 or mean gradient >40 mmHg on prior or current echocardiogram), and severe mitral
stenosis

- Severe aortic insufficiency or severe mitral regurgitation for which surgical or
percutaneous intervention is indicated.

- Documented, prior to or at the time of randomization, restrictive amyloid
myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or
constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen
on Doppler echocardiographic assessments of diastolic function).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2017
Sample size
Target
Accrual to date
Final
6600
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Novartis Investigative Site - Camperdown
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2050 - Camperdown
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2139 - Concord
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2031 - Randwick
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2065 - St Leonards
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4029 - Herston
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5041 - Bedford Park
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3220 - Geelong
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3004 - Melbourne
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6150 - Murdoch
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous
infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01870778
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01870778