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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259116
First Posted: November 29, 2005
Last Update Posted: April 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

Primary Outcome Measures:
  • Cardiac hemodynamics including PCWP, CO/CI, SVR

Secondary Outcome Measures:
  • Safety and tolerability
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259116


Locations
Germany
Charite Hospital
Berlin, Germany, 10117
Sponsors and Collaborators
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Investigators
Study Director: Sam Teichman, MD BAS Medical - Sponsor
  More Information

Responsible Party: Sam Teichman, Chief Medical Officer, BAS Medical
ClinicalTrials.gov Identifier: NCT00259116     History of Changes
Other Study ID Numbers: RLX.CHF.001
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: April 15, 2009
Last Verified: April 2009

Keywords provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:
Congestive heart failure
Relaxin
Cardiac hemodynamics

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


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