Recombinant Human Relaxin for the Treatment of Decompensated CHF - Tabular View

Tracking Information

First Received Date ^ICMJE

November 30, 2006

Last Updated Date

April 13, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cardiac hemodynamics

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00406575 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Renal function
Safety
Tolerability

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Recombinant Human Relaxin for the Treatment of Decompensated CHF

Official Title ^ICMJE

A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Brief Summary

Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Detailed Description

Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Congestive Heart Failure (CHF)

Intervention ^ICMJE

Drug: Recombinant human 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:

Hospitalization
Decompensated chronic CHF (NYHA Class III-IV)
LVEF < 35%
PCWP > 22 mmHg
CI < 2.3 L/min/m2

Exclusion Criteria:

Acute CHF
Acute coronary syndrome
Hypotension or shock
Recent stroke
Allergy or sensitivity to test agents
Significant confounding conditions or medications

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00406575

Responsible Party

Study ID Numbers ^ICMJE

RLX.CHF.002

Study Sponsor ^ICMJE

Corthera, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas Dschietzig, MD

Charite Hospital, Berlin, Germany

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