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

This study has been completed.
Sponsor:
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00259116
First received: November 28, 2005
Last updated: April 13, 2009
Last verified: April 2009
  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:


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 [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

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

ClinicalTrials.gov processed this record on October 29, 2014