EUCTR2007-004271-19-GB
Active, not recruiting
Phase 1
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. - RELAX-AHF
ConditionsPatients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.MedDRA version: 14.1 Level: LLT Classification code 10000803 Term: Acute heart failure System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients hospitalized with Acute Heart Failure (AHF), normal to elevated blood pressure, and mild to moderate renal impairment.
- Sponsor
- Corthera, Inc.
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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