A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure.
- Conditions
- Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.MedDRA version: 14.1Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-004271-19-DE
- Lead Sponsor
- Corthera, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1160
Inclusion Criteria
- Hospitalized for acute heart failure
- Dyspnea at rest or with minimal exertion
- Pulmonary congestion
- Able to provide informed consent
- Systolic blood pressure > 125 mmHg
- Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Use of other IV therapies for acute heart failure
- Fever or sepsis
- Recent major neurologic event
- Recent major surgery
- Recent acute coronary syndrome
- Other recent investigational drug use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method