search
Back to results

Recombinant Human Relaxin for the Treatment of Decompensated CHF

Primary Purpose

Congestive Heart Failure (CHF)

Status
Terminated
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Placebo
Recombinant human relaxin (rhRlx)
Sponsored by
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure (CHF) focused on measuring Congestive heart failure, Relaxin, Hemodynamics, Renal function

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Low Dose rhRlx

High Dose rhRlx

Arm Description

Participants receive diluent via continuous IV infusion for 48 hours.

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).

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).

Outcomes

Primary Outcome Measures

Cardiac hemodynamics

Secondary Outcome Measures

Renal function
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.
Safety and Tolerability assessed by number of patients with adverse events (AEs)

Full Information

First Posted
November 30, 2006
Last Updated
May 6, 2014
Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
search

1. Study Identification

Unique Protocol Identification Number
NCT00406575
Brief Title
Recombinant Human Relaxin for the Treatment of Decompensated CHF
Official Title
A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Study Start Date
November 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure (CHF)
Keywords
Congestive heart failure, Relaxin, Hemodynamics, Renal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive diluent via continuous IV infusion for 48 hours.
Arm Title
Low Dose rhRlx
Arm Type
Experimental
Arm Description
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).
Arm Title
High Dose rhRlx
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Diluent
Intervention Description
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Intervention Type
Drug
Intervention Name(s)
Recombinant human relaxin (rhRlx)
Other Intervention Name(s)
serelaxin, serelaxin (RLX030)
Intervention Description
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Primary Outcome Measure Information:
Title
Cardiac hemodynamics
Time Frame
Baseline through 27 hours post-infusion or discharge from the hospital.
Secondary Outcome Measure Information:
Title
Renal function
Description
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.
Time Frame
Baseline through Day 10
Title
Safety and Tolerability assessed by number of patients with adverse events (AEs)
Time Frame
Baseline through Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dschietzig, MD
Organizational Affiliation
Charite Hospital, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

Recombinant Human Relaxin for the Treatment of Decompensated CHF

We'll reach out to this number within 24 hrs