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Heart Failure, CongestivePhase 2/3RELAX-AHFNCT00520806

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

A Phase 2/3 study testing Relaxin in people with Heart Failure, Congestive, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Relaxin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,161 participants
Where
3 sitesin 2 countries
Study dates
Oct 2007to Sep 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Wayne State University/Detroit Receiving Hospital

    Detroit, Michigan, 48201

Other trials in United States

Israel1 site

  • Heart Institute

    Safed

Other trials in Israel

About this study

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

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Read the 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.

Being tested
Relaxin, Placebo
Keywords
Heart failure, Renal dysfunction, Relaxin, Vasodilator
Medical subject headings
Heart Failure, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelaxinDrug

    Intravenous infusion for 48 h at 30 ug/kg/day

  • PlaceboDrug

    Intravenous infusion for 48 h

Study groups in NCT00520806
Study groupRoleWhat they receive
PlaceboPlacebo comparator48 hour iv infusion of placebo
Receives: Drug: Placebo
RelaxinExperimental48 hour iv infusion of relaxin at 30 ug/kg/day
Receives: Drug: Relaxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relief of dyspnea in acute heart failure

    Measured: Up to day 5

Secondary outcomes (2)

  1. Days alive and out of hospital

    Measured: Up to day 60

  2. CV death or rehospitalization due to heart failure or renal failure

    Measured: Up to day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00520806
Sponsor's protocol ID
RLX.CHF.003
Acronym
RELAX-AHF
Status last verified
May 2012
First submitted
24 Aug 2007
Last updated
30 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35184572

  • 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.

    PubMed 34514815

  • 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.

    PubMed 27838739

  • 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.

    PubMed 25301463

  • 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.

    PubMed 25287144

  • 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.

    PubMed 23141816

  • 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.

    PubMed 22305830

  • 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.

    PubMed 21622980

  • 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.

    PubMed 19329178

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Relaxin in people with Heart Failure, Congestive, run by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relief of dyspnea in acute heart failure (time frame: Up to day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00520806, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.

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