Recombinant Human Relaxin for the Treatment of Decompensated CHF

May 6, 2014 updated by: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119992
        • Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
      • Moscow, Russian Federation, 121309
        • Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants receive diluent via continuous IV infusion for 48 hours.
Drug: Placebo
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Other Names:
  • Diluent
EXPERIMENTAL: Low Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr).
Drug: Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Other Names:
  • serelaxin
  • serelaxin (RLX030)
EXPERIMENTAL: High Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr).
Drug: Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Other Names:
  • serelaxin
  • serelaxin (RLX030)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac hemodynamics
Time Frame: Baseline through 27 hours post-infusion or discharge from the hospital.
Baseline through 27 hours post-infusion or discharge from the hospital.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function
Time Frame: Baseline through Day 10
Renal function was to be assessed by evaluation of serum creatinine, creatinine clearance, BUN, uric acid, GFR, RBF, urine output, sodium clearance, and body weight.
Baseline through Day 10
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Time Frame: Baseline through Day 30
Baseline through Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Investigators

  • Principal Investigator: Thomas Dschietzig, MD, Charité Hospital, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

January 1, 2007

Study Registration Dates

First Submitted

November 30, 2006

First Submitted That Met QC Criteria

November 30, 2006

First Posted (ESTIMATE)

December 4, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 7, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLX.CHF.002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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