A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies18 enrolled

Overview

This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.

Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability. The effects of rhRlx on hemodynamics will be assessed.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure, Congestive

Interventions

RelaxinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients over the age of 18 * New York Heart Association (NYHA) Class II-III CHF * Left Ventricular Ejection Fraction (LVEF) of \< 35% Exclusion Criteria: * Acute coronary syndrome * Acute decompensated CHF * Hypotension * Recent significant arrhythmia * Recent stroke * Significant renal or hepatic impairment * Pregnancy or child-bearing potential

Locations (1)

Charite Hospital

Berlin, Germany

Outcomes

Primary Outcomes

Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary Outcomes

Safety and tolerability

Tolerability

Data from ClinicalTrials.gov

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