Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.

Phase 1

Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Acute heart failure

Registration Number: EUCTR2013-002513-35-FR

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2685

Inclusion Criteria

- Systolic blood pressure =125 mmHg
- Admitted for AHF
- Furosemide at any time between admission and the start of screening
- eGFR on admission: =30 and =75 mL/min/1.73 m2

Other protocol-defined inclusion criteria may apply.
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 617
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2068

Exclusion Criteria

- Dyspnea (non-cardiac causes)
- T >38.5°C
- Clinical evidence of acute coronary syndrome
- AHF due to arrhythmias, acute myocarditis or cardiomyopathy

Other protocol-defined 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: Evaluate the time to Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.;Secondary Objective: - Evaluate the Time to WHF requiring rescue therapy/all cause death/readmission.<br>- Evaluate the percentage of patients with persistent signs or symptoms of HF/ non-improvement <br>- Evaluate the percentage of patients with renal deterioration. <br>- Evaluate the length of stay. <br>;Primary end point(s): - Time to Worsening of heart failure (WHF) requiring rescue therapy or all cause death through Day 5 post randomization.<br>- Time will be computed in hours from randomization to the earlier of the events. <br>;Timepoint(s) of evaluation of this end point: Through Day 5 post randomization

Secondary Outcome Measures