Evidence map›Paper›PMID 39282788›Full record

ArticleEuropean journal of heart failure2024

The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF): Rationale and design.

Lars H Lund, Stefan James, Adam D DeVore, Kevin J Anstrom, Marat Fudim, Keith D Aaronson, Ulf Dahlström, Patrice Desvigne-Nickens, Jerome L Fleg, Song Yang and 12 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in European journal of heart failure, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Heart failure with preserved ejection fraction: current insights and emerging therapeutic directions.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2026
    Review
  7. Review
  8. Heart failure evidence update 2026.Heart failure reviews · 2026
    Review
  9. Observational
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. Review
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

22 authors.

Lars H LundDepartment of Medicine, Karolinska Institutet, Sweden.ORCID https://orcid.org/0000-0003-1411-4482
Stefan JamesUppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Adam D DeVoreDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Kevin J AnstromCollaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Marat FudimDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Keith D AaronsonDivision of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Ulf DahlströmDepartment of Cardiology, Linkoping University, Linkoping, Sweden.
Patrice Desvigne-NickensDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Jerome L FlegDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Song YangDivision of Intramural Research, National Heart, Lung, and Blood Institute, Bethesda, MD, USA.
Michael FuSahlgrenska Academy and University of Gothenburg, Göteborg, Sweden.
Camilla HageDepartment of Medicine, Karolinska Institutet, Sweden.
Claes HeldUppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Patric KarlströmDepartment of Cardiology, Linkoping University, Linkoping, Sweden.
Magnus NygrenDepartment of Medicine, Karolinska Institutet, Sweden.
Eric D PetersonDepartment of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Tymon PolUppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Shelly SappDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Johan SundströmDepartment of Medical Sciences, Uppsala University, Uppsala, Sweden.
Ollie ÖstlundUppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Jonas OldgrenUppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Bertram PittDivision of Cardiovascular Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2016 to 2022
$177.0M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
SPIRRIT-HFPEF - CCCU01HL134679 · NHLBI · DUKE UNIVERSITY · PI DEVORE, ADAM D · 2017 to 2021
$8.1M
2/2 Data Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction Study (SPIRRIT-EX)U24HL173568 · NHLBI · DUKE UNIVERSITY · PI Kevin J Anstrom, Hrishikesh Chakraborty · 2024 to 2026
$1.8M
SPIRRIT-HFPEF - DCCU01HL134694 · NHLBI · DUKE UNIVERSITY · PI CHAKRABORTY, HRISHIKESH · 2017 to 2021
$1.1M
1/2 Clinical Coordinating Center for the Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction Study (SPIRRIT-EX)UG3HL173571 · NHLBI · DUKE UNIVERSITY · PI DEVORE, ADAM D · 2024 to 2024
$878k
Congestion Phenotypes and Splanchnic Nerve Modulation in Chronic Heart FailureK23HL151744 · NHLBI · DUKE UNIVERSITY · PI FUDIM, MARAT · 2021 to 2022
$376k
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001608NHLBI NIH HHS K23 HL151744NHLBI NIH HHS U01 HL134679NHLBI NIH HHS U01 HL134694NHLBI NIH HHS U24 HL173568NHLBI NIH HHS UG3 HL173571
6 · The paper itself

Abstract

aimsBenefits of mineralocorticoid receptor antagonists (MRAs) in heart failure with preserved and mildly reduced ejection fraction (HFpEF/HFmrEF) have not been established. Conventional randomized controlled trials are complex and expensive. The Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction (SPIRRIT-HFpEF) is a unique pragmatic registry-based randomized controlled trial.

methodsSPIRRIT-HFpEF is a multicentre, prospective, randomized, open-label, blinded endpoint trial conducted on platforms in the Swedish Heart Failure Registry (SwedeHF) and the United States (US) Trial Innovation Network. Patients with HFpEF/HFmrEF are randomized 1:1 to spironolactone (or eplerenone) in addition to usual care, versus usual care alone. The primary outcome is total number of cardiovascular deaths and hospitalizations for heart failure. Outcomes are collected from Swedish administrative complete coverage registries and a US call centre and subsequently adjudicated. Simple eligibility criteria were based on data available in SwedeHF: heart failure as outpatient or at discharge from hospital, left ventricular ejection fraction ≥40%, N-terminal pro-B-type natriuretic peptide >300 ng/L (in sinus rhythm) or >750 ng/L (in atrial fibrillation), with pre-specified adjustment for elevated body mass index, and chronic loop diuretic use. Power and sample size assessments were based on an event-driven design allowing enrolment over approximately 6 years, and application of hazard ratios from the TOPCAT trial, Americas subset. The final sample size is expected to be approximately 2400 patients.

conclusionSPIRRIT-HFpEF will be informative on the effectiveness of generic MRAs in HFpEF and HFmrEF, and on the feasibility of conducting pragmatic and registry-based trials in heart failure and other chronic conditions.

Indexed as

Heart FailureMineralocorticoid Receptor AntagonistsRegistriesSpironolactoneStroke VolumeAgedFemaleHumansMaleMulticenter Studies as TopicPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicSwedenUnited StatesMineralocorticoid Receptor AntagonistsSpironolactoneAldosteroneEplerenoneHeart failure with mildly reduced ejection fractionHeart failure with preserved ejection fractionMineralocorticoid receptor antagonistsPragmatic trialRegistry‐based randomized clinical trialSpironolactone

Identifiers

PMID39282788
PMCPMC11659483

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Registered trials

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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.