Evidence map›Paper›PMID 28452195›Full record

Trial reportEuropean journal of heart failure2017

Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study.

John R Teerlink, Adriaan A Voors, Piotr Ponikowski, Peter S Pang, Barry H Greenberg, Gerasimos Filippatos, G Michael Felker, Beth A Davison, Gad Cotter, Claudio Gimpelewicz and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01870778 (A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients), which is not on this map. Cited by 50 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 5 pooled it
21.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01870778 phase3completednot on this map

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2017Enrolled6,600ConditionsAcute Heart FailureArmsRLX030, Placebo
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 5 syntheses or guidelines pooled it, 121 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Highlights in heart failure.ESC heart failure · 2019
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Cardiovascular effects of relaxin-2: therapeutic potential and future perspectives.Clinical research in cardiology : official journal of the German Cardiac Society · 2024
    Review
  14. Disconnect between the effects of serelaxin on renal function and outcome in acute heart failure.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  15. Review
  16. Article
  17. Article
  18. Ligand-activated RXFP1 gene therapy ameliorates pressure overload-induced cardiac dysfunction.Molecular therapy : the journal of the American Society of Gene Therapy · 2021
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 8 countries.

John R TeerlinkSection of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.
Adriaan A VoorsDepartment of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.
Piotr PonikowskiDepartment of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland.
Peter S PangIndiana University School of Medicine, Department of Emergency Medicine and the Regenstrief Institute, Indianapolis, IN, USA.
Barry H GreenbergDivision of Cardiology, University of California, San Diego, CA, USA.
Gerasimos FilippatosAthens University Hospital Attikon, Athens, Greece.
G Michael FelkerDivision of Cardiology, Duke University School of Medicine, Durham, NC, USA.
Beth A DavisonMomentum Research, Inc., Durham, NC, USA.
Gad CotterMomentum Research, Inc., Durham, NC, USA.
Claudio GimpelewiczNovartis Pharma AG, Basel, Switzerland.
Leandro Boer-MartinsNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Margaret WernsingNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Tsushung A HuaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Thomas SeverinNovartis Pharma AG, Basel, Switzerland.
Marco MetraCardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Novartis (United States) · USMomentum Research · USNovartis (Switzerland) · CHDuke University · USIndiana University School of MedicineSurgical Specialties (Canada) · CAUniversity General Hospital Attikon · GRUniversity Medical Center Groningen · NLUniversity of California, San Diego · USUniversity of California, San Francisco · USWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients admitted for acute heart failure (AHF) experience high rates of in-hospital and post-discharge morbidity and mortality despite current therapies. Serelaxin is recombinant human relaxin-2, a hormone with vasodilatory and end-organ protective effects believed to play a central role in the cardiovascular and renal adaptations of human pregnancy. In the phase 3 RELAX-AHF trial, serelaxin met its primary endpoint of improving dyspnoea through day 5 in patients admitted for AHF. Compared to placebo, serelaxin also reduced worsening heart failure (WHF) by 47% through day 5 and both all-cause and cardiovascular mortality by 37% through day 180. RELAX-AHF-2 ( ClinicalTrials.gov NCT01870778) is designed to confirm serelaxin's effect on these clinical outcomes. RELAX-AHF-2 is a multicentre, randomized, double-blind, placebo-controlled, event-driven, phase 3 trial enrolling ∼6800 patients hospitalized for AHF with dyspnoea, congestion on chest radiograph, increased natriuretic peptide levels, mild-to-moderate renal insufficiency, and systolic blood pressure ≥125 mmHg. Patients are randomized within 16 h of presentation to 48 h intravenous infusions of serelaxin (30 µg/kg/day) or placebo, both in addition to standard of care treatments. The primary objectives are to demonstrate that serelaxin is superior to placebo in reducing: (i) 180 day cardiovascular death, and (ii) occurrence of WHF through day 5. Key secondary endpoints include 180 day all-cause mortality, composite of 180 day combined cardiovascular mortality or heart failure/renal failure rehospitalization, and in-hospital length of stay during index AHF. The results from RELAX-AHF-2 will provide data on the potential beneficial effect of serelaxin on cardiovascular mortality and WHF in selected patients with AHF.

Indexed as

Acute DiseaseAgedCause of DeathDose-Response Relationship, DrugDouble-Blind MethodEuropeFemaleFollow-Up StudiesHeart FailureHumansIncidenceInfusions, IntravenousMaleRecombinant ProteinsRelaxinRenal InsufficiencyRecombinant ProteinsRelaxinserelaxin protein, humanAcute heart failureMortalityPhase 3 trialSerelaxinWorsening heart failure

Identifiers

PMID28452195
PMCPMC5488179
OpenAlexW2609921509

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.