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

Tracking Information

First Received Date ^ICMJE

November 28, 2005

Last Updated Date

April 13, 2009

Start Date ^ICMJE

November 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cardiac hemodynamics

Change History

Complete list of historical versions of study NCT00259116 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety and tolerability [ Designated as safety issue: Yes ]
Tolerability

Original Secondary Outcome Measures ^ICMJE

Safety
Tolerability

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Heart Failure, Congestive

Intervention ^ICMJE

Drug: Relaxin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00259116

Responsible Party

Sam Teichman, Chief Medical Officer, BAS Medical

Study ID Numbers ^ICMJE

RLX.CHF.001

Study Sponsor ^ICMJE

Corthera, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Sam Teichman, MD

BAS Medical - Sponsor

Information Provided By

Corthera, Inc.

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP