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.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004271-19-HU

Enrollment

1160

Registered

2007-11-22

Start date

2008-02-26

Completion date

Unknown

Last updated

2012-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients 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 disorders

Interventions

Product Name: Relaxin Product Code: rhRlx Pharmaceutical Form: Solution for infusion Other descriptive name: Relaxin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concent

Eligibility

Sex/Gender

All

Inclusion 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: 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The Pre-RELAX-AHF Phase II pilot portion of the study has been completed. This amendment focuses on the RELAX-AHF main Phase III portion of the study. RELAX-AHF Main Phase: The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing intermediate term re-admission for HF or renal failure and cardiovascular death in subjects hospitalized for AHF with normal to elevated blood pressure and mild to moderate renal impairment. The study’s safety objective is to assess the overall safety of IV relaxin in this patient population. ;Secondary Objective: 1.Days alive out of hospital through Day 60 2.Cardiovascular death or rehospitalization due to heart failure or renal failure through Day 60;Primary end point(s): The two primary efficacy endpoints for the Phase III RELAX-AHF are: 1)Area Under the Curve (AUC) representing the change in patient-reported dyspnea from baseline measured by a 100-mm Visual Analog Scale (VAS) from baseline through Day 5 2) Moderately or markedly better patient-reported dyspnea relative to the start of study drug on the 7-point Likert scale at 6, 12 and 24 hours (at all 3 timepoints);Timepoint(s) of evaluation of this end point: Multiple	—

Measure

Time frame

Main Objective: The Pre-RELAX-AHF Phase II pilot portion of the study has been completed. This amendment focuses on the RELAX-AHF main Phase III portion of the study. RELAX-AHF Main Phase: The objectives of this phase of the study are to confirm the efficacy of IV relaxin, in addition to standard therapy, in improving symptoms of heart failure, dyspnea, and in preventing intermediate term re-admission for HF or renal failure and cardiovascular death in subjects hospitalized for AHF with normal to elevated blood pressure and mild to moderate renal impairment. The study’s safety objective is to assess the overall safety of IV relaxin in this patient population. ;Secondary Objective: 1.Days alive out of hospital through Day 60 2.Cardiovascular death or rehospitalization due to heart failure or renal failure through Day 60;Primary end point(s): The two primary efficacy endpoints for the Phase III RELAX-AHF are: 1)Area Under the Curve (AUC) representing the change in patient-reported dyspnea from baseline measured by a 100-mm Visual Analog Scale (VAS) from baseline through Day 5 2) Moderately or markedly better patient-reported dyspnea relative to the start of study drug on the 7-point Likert scale at 6, 12 and 24 hours (at all 3 timepoints);Timepoint(s) of evaluation of this end point: Multiple

—

Secondary

Measure	Time frame
Secondary end point(s): - cardiovascular death - hospitalization - renal function ;Timepoint(s) of evaluation of this end point: Multiple	—

Countries

France, Germany, Hungary, Italy, Netherlands, Spain, United Kingdom

Contacts

Public ContactClinical Development

Corthera (Europe) Ltd

eunemori@corthera.com441276-698546

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026