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Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF)

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Relaxin
Placebo
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 Heart Failure, Congestive focused on measuring Heart failure, Renal dysfunction, Relaxin, Vasodilator

Eligibility Criteria

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

Inclusion Criteria:

  • Hospitalized for acute heart failure
  • Dyspnea at rest or with minimal exertion
  • Pulmonary congestion
  • Able to provide informed consent
  • Systolic blood pressure > 125 mmHg
  • Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2

Exclusion Criteria:

  • Use of other IV therapies for acute heart failure
  • Fever or sepsis
  • Recent major neurologic event
  • Recent major surgery
  • Recent acute coronary syndrome
  • Other recent investigational drug use

Sites / Locations

  • Northwestern University
  • Wayne State University/Detroit Receiving Hospital
  • Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Relaxin

Arm Description

48 hour iv infusion of placebo

48 hour iv infusion of relaxin at 30 ug/kg/day

Outcomes

Primary Outcome Measures

Relief of dyspnea in acute heart failure

Secondary Outcome Measures

Days alive and out of hospital
CV death or rehospitalization due to heart failure or renal failure

Full Information

First Posted
August 24, 2007
Last Updated
October 26, 2012
Sponsor
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
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1. Study Identification

Unique Protocol Identification Number
NCT00520806
Brief Title
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Acronym
RELAX-AHF
Official Title
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure
Detailed Description
This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart failure, Renal dysfunction, Relaxin, Vasodilator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
48 hour iv infusion of placebo
Arm Title
Relaxin
Arm Type
Experimental
Arm Description
48 hour iv infusion of relaxin at 30 ug/kg/day
Intervention Type
Drug
Intervention Name(s)
Relaxin
Intervention Description
Intravenous infusion for 48 h at 30 ug/kg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous infusion for 48 h
Primary Outcome Measure Information:
Title
Relief of dyspnea in acute heart failure
Time Frame
Up to day 5
Secondary Outcome Measure Information:
Title
Days alive and out of hospital
Time Frame
Up to day 60
Title
CV death or rehospitalization due to heart failure or renal failure
Time Frame
Up to day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized for acute heart failure Dyspnea at rest or with minimal exertion Pulmonary congestion Able to provide informed consent Systolic blood pressure > 125 mmHg Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2 Exclusion Criteria: Use of other IV therapies for acute heart failure Fever or sepsis Recent major neurologic event Recent major surgery Recent acute coronary syndrome Other recent investigational drug use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Severin, MD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Wayne State University/Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Heart Institute
City
Safed
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
35184572
Citation
Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
Results Reference
derived
PubMed Identifier
34514815
Citation
Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
Results Reference
derived
PubMed Identifier
27838739
Citation
Meyer S, Teerlink JR, Metra M, Ponikowski P, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Hua TA, Severin T, Qian M, Voors AA. Sex differences in early dyspnea relief between men and women hospitalized for acute heart failure: insights from the RELAX-AHF study. Clin Res Cardiol. 2017 Apr;106(4):280-292. doi: 10.1007/s00392-016-1051-4. Epub 2016 Nov 12.
Results Reference
derived
PubMed Identifier
25301463
Citation
Felker GM, Teerlink JR, Butler J, Hernandez AF, Miller AB, Cotter G, Davison BA, Filippatos G, Greenberg BH, Ponikowski P, Voors AA, Hua TA, Severin TM, Unemori E, Metra M. Effect of serelaxin on mode of death in acute heart failure: results from the RELAX-AHF study. J Am Coll Cardiol. 2014 Oct 14;64(15):1591-8. doi: 10.1016/j.jacc.2014.05.071.
Results Reference
derived
PubMed Identifier
25287144
Citation
Voors AA, Davison BA, Teerlink JR, Felker GM, Cotter G, Filippatos G, Greenberg BH, Pang PS, Levin B, Hua TA, Severin T, Ponikowski P, Metra M; RELAX-AHF Investigators. Diuretic response in patients with acute decompensated heart failure: characteristics and clinical outcome--an analysis from RELAX-AHF. Eur J Heart Fail. 2014 Nov;16(11):1230-40. doi: 10.1002/ejhf.170. Epub 2014 Oct 7.
Results Reference
derived
PubMed Identifier
23141816
Citation
Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Ponikowski P, Unemori E, Voors AA, Adams KF Jr, Dorobantu MI, Grinfeld LR, Jondeau G, Marmor A, Masip J, Pang PS, Werdan K, Teichman SL, Trapani A, Bush CA, Saini R, Schumacher C, Severin TM, Metra M; RELAXin in Acute Heart Failure (RELAX-AHF) Investigators. Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet. 2013 Jan 5;381(9860):29-39. doi: 10.1016/S0140-6736(12)61855-8. Epub 2012 Nov 7.
Results Reference
derived
PubMed Identifier
22305830
Citation
Ponikowski P, Metra M, Teerlink JR, Unemori E, Felker GM, Voors AA, Filippatos G, Greenberg B, Teichman SL, Severin T, Mueller-Velten G, Cotter G, Davison BA. Design of the RELAXin in acute heart failure study. Am Heart J. 2012 Feb;163(2):149-55.e1. doi: 10.1016/j.ahj.2011.10.009.
Results Reference
derived
PubMed Identifier
21622980
Citation
Voors AA, Davison BA, Felker GM, Ponikowski P, Unemori E, Cotter G, Teerlink JR, Greenberg BH, Filippatos G, Teichman SL, Metra M; Pre-RELAX-AHF study group. Early drop in systolic blood pressure and worsening renal function in acute heart failure: renal results of Pre-RELAX-AHF. Eur J Heart Fail. 2011 Sep;13(9):961-7. doi: 10.1093/eurjhf/hfr060. Epub 2011 May 28.
Results Reference
derived
PubMed Identifier
19329178
Citation
Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G. Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study. Lancet. 2009 Apr 25;373(9673):1429-39. doi: 10.1016/S0140-6736(09)60622-X. Epub 2009 Mar 28.
Results Reference
derived

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Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

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