Recombinant Human Relaxin for the Treatment of Decompensated CHF

Corthera

Status and phase: Terminated; Phase 2

Conditions: Congestive Heart Failure (CHF)

Treatments: Drug: Placebo; Drug: Recombinant human relaxin (rhRlx)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00406575

RLX.CHF.002

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants receive diluent via continuous IV infusion for 48 hours.

Treatment:

Drug: Placebo

Low Dose rhRlx

Experimental group

Description:

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).

Treatment:

Drug: Recombinant human relaxin (rhRlx)

High Dose rhRlx

Experimental group

Description:

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).

Treatment:

Drug: Recombinant human relaxin (rhRlx)