Evidence map›Paper›PMID 35861823›Full record

Trial reportJournal of the American Heart Association2022

Characteristics Associated With Growth Differentiation Factor 15 in Heart Failure With Preserved Ejection Fraction and the Impact of Pirfenidone.

Gavin A Lewis, Anna Rosala-Hallas, Susanna Dodd, Erik B Schelbert, Simon G Williams, Colin Cunnington, Theresa McDonagh, Christopher A Miller

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Heart Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02932566 (A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT02932566 phase2completednot on this map

A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PIROUETTE)

TypeinterventionalSponsorManchester University NHS Foundation TrustRan2017 to 2020Enrolled129ConditionsCardiac FailureArmsPirfenidone, Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  4. Review
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  7. Article
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  9. Article
  10. Cardiac fibrosis: from mechanisms and models to medicines.Trends in pharmacological sciences · 2025
    Review
  11. Article
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  15. Article
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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

8 authors at 5 institutions in 2 countries.

Gavin A LewisDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre University of Manchester Manchester United Kingdom.ORCID 0000-0001-6754-836X
Anna Rosala-HallasLiverpool Clinical Trials Centre, Clinical Directorate, Faculty of Health and Life Sciences, University of Liverpool (a member of Liverpool Health Partners) Alder Hey Children's NHS Foundation Trust Liverpool United Kingdom.ORCID 0000-0001-8012-9995
Susanna DoddDepartment of Health Data Science, Institute of Population Health, Faculty of Health and Life Sciences University of Liverpool (a member of Liverpool Health Partners) Liverpool United Kingdom.ORCID 0000-0003-2851-3337
Erik B SchelbertDepartment of Medicine University of Pittsburgh School of Medicine Pittsburgh PA.ORCID 0000-0003-0356-4437
Simon G WilliamsManchester University NHS Foundation Trust Manchester United Kingdom.
Colin CunningtonManchester University NHS Foundation Trust Manchester United Kingdom.
Theresa McDonaghKing's College Hospital London United Kingdom.
Christopher A MillerDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre University of Manchester Manchester United Kingdom.ORCID 0000-0002-5957-7088
Manchester Academic Health Science Centre · GBManchester University NHS Foundation Trust · GBUniversity of Liverpool · GBKing's College Hospital · GBUniversity of Pittsburgh · US

Funding

Academy of Medical Sciences AMS-SGCL12-MILLERBritish Heart Foundation FS/17/47/32805
6 · The paper itself

Abstract

Background Growth differentiation factor 15 (GDF-15) is elevated in heart failure with preserved ejection fraction and is associated with adverse outcome, but its relationship with myocardial fibrosis and other characteristics remains unclear. We sought to evaluate the effect of pirfenidone, a novel antifibrotic agent, on GDF-15 in heart failure with preserved ejection fraction and identify characteristics that associate with GDF-15 and with change in GDF-15 over 1 year. Methods and Results Among patients enrolled (n=107) in the PIROUETTE (Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction) trial, GDF-15 was measured at baseline and at prespecified time points in patients randomized (n=94) to pirfenidone or placebo. The response of GDF-15 to pirfenidone and the association with baseline patient characteristics were evaluated. Pirfenidone had no impact on circulating GDF-15 at any time point during the 52-week trial period. In multivariable analysis, male sex, diabetes, higher circulating levels of N-terminal pro-B-type natriuretic peptide, lower renal function, and shorter 6-minute walk test distance at baseline were associated with baseline log-GDF-15. Impaired global longitudinal strain at baseline was the strongest predictor of increased GDF-15 over 52 weeks. Conclusions In patients with heart failure with preserved ejection fraction, circulating levels of GDF-15 were unaffected by treatment with pirfenidone and do not appear to be determined by myocardial fibrosis. Circulating GDF-15 was associated with a spectrum of important heart failure characteristics and it may represent a marker of overall physiological disruption. Registration URL: https://clinicaltrials.gov/ct2/show/NCT02932566; Unique identifier: NCT02932566.

Indexed as

Heart FailureVentricular Function, LeftFibrosisGrowth Differentiation Factor 15HumansMalePyridonesStroke VolumeGrowth Differentiation Factor 15pirfenidonePyridonesextracellular volumeheart failuremagnetic resonance imagingmyocardial fibrosis

Identifiers

PMID35861823
PMCPMC9707842
OpenAlexW4285391751

What OpenQuestion holds

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LicenceCC BY-NC
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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.