Evidence map›Paper›PMID 26374849›Full record

Trial reportEuropean heart journal2016

Influence of ejection fraction on outcomes and efficacy of spironolactone in patients with heart failure with preserved ejection fraction.

Scott D Solomon, Brian Claggett, Eldrin F Lewis, Akshay Desai, Inder Anand, Nancy K Sweitzer, Eileen O'Meara, Sanjiv J Shah, Sonja McKinlay, Jerome L Fleg and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00094302 (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist), which is not on this map. Cited by 224 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
224citing papers in PubMed, 7 pooled it
–field-weighted citation impact
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.

NCT00094302 phase3completednot on this map

Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)

TypeinterventionalSponsorCarelon ResearchRan2006 to 2013Enrolled3,445ConditionsCardiovascular Diseases, Heart Diseases, Heart Failure, CongestiveArmsSpironolactone, Placebo
3 · Its place in the literature

Who cites it

224 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  5. Highlights in heart failure.ESC heart failure · 2019
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164 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Scott D SolomonCardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA ssolomon@rics.bwh.harvard.edu.
Brian ClaggettCardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.
Eldrin F LewisCardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.
Akshay DesaiCardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.
Inder AnandMinneapolis VA Hospital, Minneapolis, MN, USA.
Nancy K SweitzerUniversity of Arizona, Tuscon, AZ, USA.
Eileen O'MearaMontreal Heart Institute, Montreal, Canada.
Sanjiv J ShahNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Sonja McKinlayNew England Research Institute, Watertown, MA, USA.
Jerome L FlegNational Heart, Lung and Blood Institute, Bethesda, MD, USA.
George SopkoNational Heart, Lung and Blood Institute, Bethesda, MD, USA.
Bertram PittUniversity of Michigan, Ann Arbor, MI, USA.
Marc A PfefferCardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA.
TOPCAT Investigators

Funding

Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
NCATS NIH HHS UL1 TR000427PHS HHS HHSN268200425207C
6 · The paper itself

Abstract

aimsWhile mineralocorticoid receptor antagonists (MRAs) have been shown to benefit patients with reduced left ventricular ejection fraction (LVEF), spironolactone did not reduce the primary endpoint of cardiovascular death, heart failure hospitalization, or aborted cardiac arrest in patients with heart failure with preserved ejection fraction (HFpEF) in the TOPCAT trial, which enrolled patients with LVEF of 45% or greater. We utilized data from TOPCAT to assess the relationship between LVEF as well as outcomes and efficacy of spironolactone. METHODS AND

resultsWe assessed differences in baseline characteristics and outcomes across LVEF categories in 3444 patients with HFpEF, and determined whether LVEF modified the treatment effect of spironolactone. Ejection fraction ranged from 44 to 85%. Patients with higher ejection fraction were older, more likely to be female, less likely to have a history of myocardial infarction, and more likely to have a history of hypertension and diabetes. The incidence of the primary endpoint and cardiovascular death was highest in patients at the lower end of the ejection fraction spectrum. Ejection fraction modified the spironolactone treatment effect, particularly in the patients enrolled in the Americas, for the primary outcome (P = 0.046) and for heart failure hospitalization (P = 0.039), with stronger estimated benefits of spironolactone at the lower end of the ejection fraction spectrum with respect to the primary endpoint (LVEF <50%: HR 0.72, 95% CI 0.50, 1.05; LVEF ≥60%: HR 0.97, 95% CI 0.76, 1.23) and heart failure hospitalization (LVEF <50%: HR 0.76, 95% CI 0.46, 1.27; LVEF ≥60%: HR 0.98, 95% CI 0.74, 1.30).

conclusionIn patients with HFpEF enrolled in TOPCAT, patient characteristics and outcomes varied substantially by LVEF. The potential efficacy of spironolactone was greatest at the lower end of the LVEF spectrum. CLINICALTRIALSGOV NUMBER: NCT00094302.

Indexed as

AgedDouble-Blind MethodDrug Administration ScheduleFemaleHeart FailureHeart RateHospitalizationHumansMaleMiddle AgedMineralocorticoid Receptor AntagonistsSpironolactoneStroke VolumeTreatment OutcomeMineralocorticoid Receptor AntagonistsSpironolactoneHeart failure with preserved ejection fractionSpironolactone

Identifiers

PMID26374849
PMCPMC4751235

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.