Recombinant Human Relaxin for the Treatment of Decompensated CHF

A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406575

Enrollment

Registered

2006-12-04

Start date

2006-11-30

Completion date

2007-01-31

Last updated

2014-05-07

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

Conditions

Congestive Heart Failure (CHF)

Keywords

Congestive heart failure, Relaxin, Hemodynamics, Renal function

Brief summary

Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Detailed description

Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Interventions

DRUGPlacebo

Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.

DRUGRecombinant human relaxin (rhRlx)

Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hospitalization * Decompensated chronic CHF (NYHA Class III-IV) * LVEF \< 35% * PCWP \> 22 mmHg * CI \< 2.3 L/min/m2

Exclusion criteria

* Acute CHF * Acute coronary syndrome * Hypotension or shock * Recent stroke * Allergy or sensitivity to test agents * Significant confounding conditions or medications

Design outcomes

Primary

Measure	Time frame
Cardiac hemodynamics	Baseline through 27 hours post-infusion or discharge from the hospital.

Secondary

Measure	Time frame	Description
Renal function	Baseline through Day 10	Renal function was to be assessed by evaluation of serum creatinine, creatinine clearance, BUN, uric acid, GFR, RBF, urine output, sodium clearance, and body weight.
Safety and Tolerability assessed by number of patients with adverse events (AEs)	Baseline through Day 30	—

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026