Spironolactone for heart failure with preserved ejection fraction
Open accessAbstract
BACKGROUND: Mineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction. METHODS: In this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. RESULTS: With a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 μmol per liter) or higher, or dialysis. CONCLUSIONS: In patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.).
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Steroidal MRA, such as spironolactone and eplerenone, have established cardiovascular benefits in those with heart failure and are useful for treating primary hyperaldosteronism and refractory hypertension.
“Steroidal MRA, such as spironolactone and eplerenone, have established cardiovascular bene fi ts in those with heart failure and are useful for treating primary hyperaldosteronism and refractory hypertension.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [156]
The Background and Conclusions passages state that mineralocorticoid-receptor antagonists improve outcomes in heart failure with reduced ejection fraction. The paper does not establish their usefulness for primary hyperaldosteronism or refractory hypertension; its Discussion also reports that spironolactone did not significantly reduce the primary outcome in heart failure with preserved ejection fraction. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSteroidal MRA are standard of care for treatment of heart failure (particularly with reduced ejection fraction) and primary hyperaldosteronism.
“Steroidal MRA are standard of care for treatment of heart failure (particularly with reduced ejection fraction) and primary hyperaldosteronism.”
From KDIGO 2022 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Disease (2022) · cites this paper as [156]
The Background and Conclusions (page not provided) state that mineralocorticoid-receptor antagonists improve outcomes in heart failure with reduced ejection fraction. The paper does not address their use for primary hyperaldosteronism, and its trial found no significant reduction in the primary outcome for heart failure with preserved ejection fraction. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSteroidal MRA are useful for management of heart failure as well as primary hyperaldosteronism and resistant hypertension.
“Steroidal MRA are useful for management of heart failure as well as primary hyperaldosteronism and resistant hypertension.32,33”
Clinical trial results are somewhat conflicting regarding the risk of all-cause and cardiovascular mortality attributed to T2DM in HF patients, but most clinical trials reported an increased risk of death in patients with concurrent T2DM and HF.
“Clinical trial results are somewhat conflicting regarding the risk of all-cause and CV mortality attributed to T2DM in HF patients, but most clinical trials reported an increased risk of death in patients with concurrent T2DM and HF (Table 5).1,31 -35,37,40,42,44,45,69,88-92”
From Type 2 diabetes mellitus and heart failure: A position statement from the Heart Failure Association of the European Society of Cardiology (2018) · cites this paper as [44]
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Clinical implications of the New York Heart Association classification
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Self-citationMetabolic inflammation in heart failure with preserved ejection fraction
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Self-citationObesity-Related Heart Failure With a Preserved Ejection Fraction
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Self-citationAtrial Fibrillation and Hypertension
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Self-citationThe cardioprotective effects of semaglutide exceed those of dietary weight loss in mice with HFpEF
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- Authors
- Pitt, B., Pfeffer, M. A., Assmann, S. F., Boineau, R., Anand, I. S., Claggett, B., Clausell, N., Desai, A. S., Diaz, R., Fleg, J. L., Gordeev, I., Harty, B., Heitner, J. F., Kenwood, C. T., Lewis, E. F., O'Meara, E., Probstfield, J. L., Shaburishvili, T., Shah, S. J., Solomon, S. D., Sweitzer, N. K., Yang, S., & McKinlay, S. M.
- Affiliations
- Brigham and Women's Hospital (US)
- New England Research Institutes (US)
- National Heart, Lung, and Blood Institute (US)
- University of Minnesota (US)
- Hospital de Clínicas de Porto Alegre (BR)
- Pirogov Russian National Research Medical University (RU)
- NewYork–Presbyterian Brooklyn Methodist Hospital (US)
- University of Washington Medical Center (US)
- Georgian National Museum (GE)
- Northwestern University (US)
- University of Wisconsin–Madison (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2014-04-10
- Volume
- 370
- Issue
- 15
- Pages
- 1383-1392
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2152072062
- Cited by
- 2,809
- References
- 39
- Citations by year
- 2026: 226 · 2025: 262 · 2024: 238 · 2023: 231 · 2022: 308 · 2021: 277 · 2020: 254 · 2019: 210 · 2018: 210 · 2017: 200 · 2016: 149 · 2015: 161 · 2014: 78 · 2013: 2
- FWCI
- 134.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Public Health Service (HHSN268200425207C)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal Regulation and Hypertension
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Keywords
- spironolactone, heart failure with preserved ejection fraction, mineralocorticoid receptor antagonists, cardiovascular mortality, heart failure hospitalization, hyperkalemia, serum creatinine, TOPCAT trial, adverse events, left ventricular ejection fraction, dialysis, cardiac arrest, renin-angiotensin system blockade, renin-angiotensin-aldosterone system inhibitors
- MeSH terms
- Aged, Aged, 80 and over, Mineralocorticoid Receptor Antagonists, Cardiovascular Diseases, Double-Blind Method, Female, Follow-Up Studies, Heart Failure, Hospitalization, Humans, Male, Middle Aged, Spironolactone, Stroke Volume, Incidence, Treatment Failure, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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