Recombinant Human Relaxin for the Treatment of Decompensated CHF

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

Detailed Description
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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.

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

Conditions
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Congestive Heart Failure (CHF)

Intervention / Treatment
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* Drug: Placebo
* Drug: Recombinant human relaxin (rhRlx)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants receive diluent via continuous IV infusion for 48 hours. | Drug: Placebo<br>* Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.<br>* Other names: Diluent;|
| Experimental: Low Dose rhRlx<br>Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr). | Drug: Recombinant human relaxin (rhRlx)<br>* Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.<br>* Other names: serelaxin (RLX030);|
| Experimental: High Dose rhRlx<br>Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr). | Drug: Recombinant human relaxin (rhRlx)<br>* Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.<br>* Other names: serelaxin (RLX030);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac hemodynamics |  | Baseline through 27 hours post-infusion or discharge from the hospital. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | 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. | Baseline through Day 10 | 
| Safety and Tolerability assessed by number of patients with adverse events (AEs) |  | Baseline through Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive heart failure, Relaxin, Hemodynamics, Renal function