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

Phase 1

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

• Registration Number: EUCTR2013-002513-35-ES
• Lead Sponsor: ovartis Farmacéutica, S. A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-04
• Last Update Posted: 29 May 2017

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