Efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure
- Conditions
- Acute heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001498-25-EE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6375
-Male or female 18 years of age, with body weight =160 kg
-Hospitalized for AHF, i.e. Dyspnea at rest or with minimal exertion, Pulmonary congestion on chest radiograph, BNP =350 pg/mL or NT-proBNP =1,400 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1470
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4905
-Dyspnea primarily due to non-cardiac causes
-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 eGFR < 25mL/min/1.73m2 calculated using the sMDRD equation, and/or those receiving current or planned dialysis or ultrafiltration Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Time to confirmed cardiovascular (CV) death during the follow-up period of 180 days;Secondary Objective: -Time to all-cause death through Day 180<br>-Time to worsening of heart failure (WHF) through Day 5 (considering death in the 5-day)<br>-Length of total hospital stay (LOS) during the index acute heart faliure (AHF) hospitalization<br>-Time to first occurrence of the composite endpoint of CV death or rehospitalization due to heart failure or renal failure through day 180<br>-Lenght of Intensive Care Unit (ICU) and/or Coronary care unit (CCU) stay for the index AHF hospitalization<br>-Change from baseline in congestive signs and symptoms of heart failure through Day 5<br>-Number of patients reported with total adverse events, serious adverse events and death;Primary end point(s): time to confirmed CV death;Timepoint(s) of evaluation of this end point: throughout a period of 180 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy:<br>• Time to all-cause death<br>• Time to first occurrence of worsening of heart failure <br>• Length of total hospital stay for the index AHF hospitalization<br>• Time to first occurrence of the composite endpoint of CV death or rehospitalization due to heart failure/renal failure<br>• Length of ICU and/or CCU stay for the index AHF hospitalization<br>• Change from baseline in congestive signs and symptoms of HF.<br>• Number of patients reported with total adverse events, serious adverse events and death;Timepoint(s) of evaluation of this end point: Throughout a period of 180 days except for:<br>Time to first occurrence of worsening of heart failure and change from baseline in congestive signs and symptoms of HF where evaluation will be conducted through Day 5.<br>