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

This study has been completed.
Sponsor:
Information provided by:
Corthera, Inc.
ClinicalTrials.gov Identifier:
NCT00259116
First received: November 28, 2005
Last updated: April 13, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
 Drug: Relaxin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Corthera, Inc.:

Primary Outcome Measures:
  • Cardiac hemodynamics including PCWP, CO/CI, SVR [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Tolerability

Estimated Enrollment: 18
Study Start Date: November 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259116

Locations
Germany
Charite Hospital
Berlin, Germany, 10117
Sponsors and Collaborators
Corthera, Inc.
Investigators
Study Director: Sam Teichman, MD BAS Medical - Sponsor
  More Information

No publications provided

Responsible Party: Sam Teichman, Chief Medical Officer, BAS Medical
ClinicalTrials.gov Identifier: NCT00259116     History of Changes
Other Study ID Numbers: RLX.CHF.001
Study First Received: November 28, 2005
Last Updated: April 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Corthera, Inc.:
Congestive heart failure
Relaxin
Cardiac hemodynamics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
 Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013