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

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.
 
ClinicalTrials.gov Identifier: NCT00259116
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Relaxin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
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
Study Start Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




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

Secondary Outcome Measures :
  1. Safety and tolerability
  2. Tolerability


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
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

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

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Responsible Party: Sam Teichman, Chief Medical Officer, BAS Medical
ClinicalTrials.gov Identifier: NCT00259116    
Other Study ID Numbers: RLX.CHF.001
First Posted: November 29, 2005    Key Record Dates
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents