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

IF 10.8 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Journal of Heart Failure Pub Date : 2024-09-16 DOI:10.1002/ejhf.3453

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, Michael Fu, Camilla Hage, Claes Held, Patric Karlström, Magnus Nygren, Eric D. Peterson, Tymon Pol, Shelly Sapp, Johan Sundström, Ollie Östlund, Jonas Oldgren, Bertram Pitt

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Abstract

Aims

Benefits 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.

Methods

SPIRRIT-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.

Conclusion

SPIRRIT-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.

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保留射血分数的心力衰竭患者螺内酯起始注册随机介入试验（SPIRRIT-HFpEF）：原理与设计

矿物皮质激素受体拮抗剂（MRAs）对射血分数保留和轻度降低的心力衰竭（HFpEF/HFmrEF）的疗效尚未确定。传统的随机对照试验既复杂又昂贵。保留射血分数的心力衰竭患者螺内酯起始注册随机介入试验（SPIRRIT-HFpEF）是一项独特、务实的基于注册的随机对照试验。

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来源期刊

European Journal of Heart Failure 医学-心血管系统

CiteScore

27.30

自引率

11.50%

发文量

365

审稿时长

1 months

期刊介绍： European Journal of Heart Failure is an international journal dedicated to advancing knowledge in the field of heart failure management. The journal publishes reviews and editorials aimed at improving understanding, prevention, investigation, and treatment of heart failure. It covers various disciplines such as molecular and cellular biology, pathology, physiology, electrophysiology, pharmacology, clinical sciences, social sciences, and population sciences. The journal welcomes submissions of manuscripts on basic, clinical, and population sciences, as well as original contributions on nursing, care of the elderly, primary care, health economics, and other related specialist fields. It is published monthly and has a readership that includes cardiologists, emergency room physicians, intensivists, internists, general physicians, cardiac nurses, diabetologists, epidemiologists, basic scientists focusing on cardiovascular research, and those working in rehabilitation. The journal is abstracted and indexed in various databases such as Academic Search, Embase, MEDLINE/PubMed, and Science Citation Index.