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OpenTrials
Completed

NCT Number: NCT00259116

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

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.

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charite Hospital

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

relaxin

Drug

Primary outcomes

  1. Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary outcomes

  1. Safety and tolerability

  2. Tolerability

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Important dates

Study start
2005
First posted
Nov 29, 2005
Registry last updated
Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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