Evidence map›Paper›PMID 23258572›Full record

Trial reportCirculation. Heart failure2013

Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial.

Sanjiv J Shah, John F Heitner, Nancy K Sweitzer, Inder S Anand, Hae-Young Kim, Brian Harty, Robin Boineau, Nadine Clausell, Akshay S Desai, Rafael Diaz and 11 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation. Heart failure, 2013. 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 103 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
103citing papers in PubMed, 7 pooled it
9.3field-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.

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

103 citing papers in PubMed, 7 syntheses or guidelines pooled it, 179 citations in OpenAlex.

  1. Pooled it
  2. Pharmacotherapy for hypertension-induced left ventricular hypertrophy.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Electrocardiographic characteristics in patients with heart failure and normal ejection fraction: A systematic review and meta-analysis.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2020
    Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

43 more citing papers are in PubMed but not listed here.

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

21 authors at 5 institutions in 4 countries.

Sanjiv J ShahDivision of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. sanjiv.shah@northwestern.edu
John F Heitner
Nancy K Sweitzer
Inder S Anand
Hae-Young Kim
Brian Harty
Robin Boineau
Nadine Clausell
Akshay S Desai
Rafael Diaz
Jerome L Fleg
Ivan Gordeev
Eldrin F Lewis
Valetin Markov
Eileen O'Meara
Bondo Kobulia
Tamaz Shaburishvili
Scott D Solomon
Bertram Pitt
Marc A Pfeffer
Rebecca Li
Diagnostic Services Manitoba · CAEstudios Clínicos Latinoamérica · ARScientific Research Institute of Healthcare Organization and Medical Management · RUUniversidade Federal do Rio Grande do Sul · BRUniversité de Montréal · CA

Funding

Treatment of Preserved Systolic Function with an Aldosterone AntagonistN01HC45207 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI LI, REBECCA · 2007 to 2014
$18.0M
Multidisciplinary Clinical and Translational Science (MCTS) Program (UL1)UL1TR000150 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI LLOYD-JONES, DONALD M · 2012 to 2013
$10.1M
ALDOSTERONE ANTAGONISTS FOR THE TREATMENT OF HEART FAILURE WITH PRESER-N01HC45207N01HC045207 · HC · NEW ENGLAND RESEARCH INSTITUTES. INC · PI MCKINLAY, SONJA M · 2004 to 2006
–
NCATS NIH HHS UL1 TR000150NHLBI NIH HHS N01 HC045207NHLBI NIH HHS N01 HC45207
6 · The paper itself

Abstract

backgroundTreatment of Preserved Cardiac Function with an Aldosterone Antagonist (TOPCAT) is an ongoing randomized controlled trial of spironolactone versus placebo for heart failure with preserved ejection fraction (HFpEF). We sought to describe the baseline clinical characteristics of subjects enrolled in TOPCAT relative to other contemporary observational studies and randomized clinical trials of HFpEF. METHODS AND

resultsBetween August 2006 and January 2012, 3445 patients with symptomatic HFpEF from 270 sites in 6 countries were enrolled in TOPCAT. At the baseline study visit, all subjects provided a detailed medical history and underwent physical examination, electrocardiography, quality of life, and laboratory assessment. Key parameters were compared with other large, contemporary HFpEF studies. The mean age was 68.6±9.6 years with a slight female predominance (52%); mean body mass index was 32 kg/m2; and comorbidities were common. History of hypertension (91% prevalence in TOPCAT) exceeded all other major HFpEF clinical trials. However, baseline blood pressure was well controlled (129/76 mm Hg; systolic blood pressure 7-16 mm Hg lower than other similar trials). Other common comorbidities included coronary artery disease (57%), atrial fibrillation (35%), chronic kidney disease (38%) and diabetes mellitus (32%). Self-reported activity levels were low, quality of life scores were comparable with those reported for patients with end-stage renal disease, and the prevalence of moderate or greater depression was 27%.

conclusionsTOPCAT subjects share many common characteristics with contemporary HFpEF cohorts. Low activity level, significantly decreased quality of life, and depression were common at baseline in TOPCAT, underscoring the continued unmet need for evidence-based treatment strategies in HFpEF. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302.

Indexed as

Stroke VolumeAgedArgentinaComorbidityDepressionDouble-Blind MethodElectrocardiographyFemaleHeart FailureHumansLife StyleMaleMiddle AgedMineralocorticoid Receptor AntagonistsPhysical ExaminationPredictive Value of TestsMineralocorticoid Receptor AntagonistsSpironolactone

Identifiers

PMID23258572
PMCPMC3605409
OpenAlexW2110392728

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.