drugset / Trial / NCT00094302
Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
Phase 3
Completed
3445 enrolled
Carelon Research
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.
Timeline
- Start
- 2006-08
- Primary completion
- 2013-06
- Completion
- 2013-06
Outcome
Missed primary endpoint
registry Placebo vs Spironolactone; p = 0.14; Hazard Ratio (HR) 0.89 (95% CI 0.77 to 1.04) NCT00094302 ↗
paper treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome PMID 24716680 ↗
Publications
- Background Desai AS, Lewis EF, Li R, Solomon SD, Assmann SF, Boineau R, Clausell N, Diaz R, Fleg JL, Gordeev I, McKinlay S, O'Meara E, Shaburishvili T, Pitt B, Pfeffer MA. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am Heart J. 2011 Dec;162(6):966-972.e10. doi: 10.1016/j.ahj.2011.09.007. Epub 2011 Nov 8.
- Results Shah SJ, Heitner JF, Sweitzer NK, Anand IS, Kim HY, Harty B, Boineau R, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Lewis EF, Markov V, O'Meara E, Kobulia B, Shaburishvili T, Solomon SD, Pitt B, Pfeffer MA, Li R. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail. 2013 Mar;6(2):184-92. doi: 10.1161/CIRCHEARTFAILURE.112.972794. Epub 2012 Dec 20.
- Results Shah AM, Shah SJ, Anand IS, Sweitzer NK, O'Meara E, Heitner JF, Sopko G, Li G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Cardiac structure and function in heart failure with preserved ejection fraction: baseline findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. Circ Heart Fail. 2014 Jan;7(1):104-15. doi: 10.1161/CIRCHEARTFAILURE.113.000887. Epub 2013 Nov 18.
- Results Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. doi: 10.1056/NEJMoa1313731.
- Results Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, O'Meara E, Desai AS, Heitner JF, Li G, Fang J, Rouleau J, Zile MR, Markov V, Ryabov V, Reis G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD. Cardiac structure and function and prognosis in heart failure with preserved ejection fraction: findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) Trial. Circ Heart Fail. 2014 Sep;7(5):740-51. doi: 10.1161/CIRCHEARTFAILURE.114.001583. Epub 2014 Aug 13.
- Results Pfeffer MA, Claggett B, Assmann SF, Boineau R, Anand IS, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Heitner JF, Lewis EF, O'Meara E, Rouleau JL, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, McKinlay SM, Pitt B. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015 Jan 6;131(1):34-42. doi: 10.1161/CIRCULATIONAHA.114.013255. Epub 2014 Nov 18.
- Nguyen DV, Nguyen HTT. Spironolactone and New-Onset Diabetes in Heart Failure: A Post Hoc Analysis of the TOPCAT Trial. JACC Asia. 2026 Jun 3:S2772-3747(26)00267-X. doi: 10.1016/j.jacasi.2026.04.010. Online ahead of print.
- Zhu W, Guo L, Chen X, Ye M. Prognostic Utility of the HFpEF-ABA Score for HFpEF Patients: Insights From the TOPCAT Trial. JACC Adv. 2026 Mar;5(3):102632. doi: 10.1016/j.jacadv.2026.102632. Epub 2026 Feb 25.
- Tang Y, Li W, Wang Z, Chu SH, Wu Y, Jia Z, Hua C, Zhang H, Liu X, Lv Q, Jiang C, Dong JZ, Ma CS, Du X. Changes in frailty based on minimally important difference and the impact of spironolactone on frailty in heart failure with preserved ejection fraction: insights from the TOPCAT trial. Open Heart. 2025 Oct 22;12(2):e003487. doi: 10.1136/openhrt-2025-003487.
- Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2026 Feb 1;37(2):390-393. doi: 10.1681/ASN.0000000877. Epub 2025 Sep 2. No abstract available.
- Xu W, Xiao Z, Tang Y, Li Y, Chen X, He F, Huang H, Li C, Liu Y, Zhou J, Wang Y, Bin J, Chen Y. Association of serum potassium time in target range with cardiovascular outcomes in patients with HFpEF. Open Heart. 2025 Aug 21;12(2):e003439. doi: 10.1136/openhrt-2025-003439.
- Ferreira JP, Zannad F. Screening for Undiagnosed Heart Failure: A Viewpoint. J Card Fail. 2025 Aug;31(8):1339-1344. doi: 10.1016/j.cardfail.2025.04.016. Epub 2025 May 23.
- Xing F, Gao M, Wu Y, Liang W, Jiang J, Dong YG, Li Y, Dong B, Liu C. Influence of depression trajectories in heart failure patients with preserved ejection fractions: a secondary analysis of adverse outcomes in the TOPCAT trial. Heart. 2025 Jul 14;111(15):733-740. doi: 10.1136/heartjnl-2024-324505.
- Fu Y, Feng S, Gu Z, Liu X, Zhu W, Wei B, Guo L. Associations of Depression, Antidepressants with Atrial Fibrillation Risk in HFpEF Patients. Rev Cardiovasc Med. 2024 Oct 22;25(10):370. doi: 10.31083/j.rcm2510370. eCollection 2024 Oct.
- Zhang Q, Tai S, Zhou S. Abdominal obesity is associated with increased worsening renal function risk in patients with heart failure with preserved ejection fraction. BMC Cardiovasc Disord. 2024 Sep 9;24(1):477. doi: 10.1186/s12872-024-04118-0.
- Desai RJ, Glynn RJ, Solomon SD, Claggett B, Wang SV, Vaduganathan M. Individualized Treatment Effect Prediction with Machine Learning - Salient Considerations. NEJM Evid. 2024 Apr;3(4):EVIDoa2300041. doi: 10.1056/EVIDoa2300041. Epub 2024 Mar 26.
- Pfeffer MA, Claggett B. Behind the Scenes of TOPCAT - Bending to Inform. NEJM Evid. 2022 Jan;1(1):EVIDctcs2100007. doi: 10.1056/EVIDctcs2100007. Epub 2022 Jan 10.
- Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
- Huang X, Liu X, Jiang Y, Cao Z, Wu M, Chen Z, Sun R, Yu P, Ma J, Zhu W, Chen Y, Wu G, Zhang Y, Wang J. Association of Body Mass Index and Abdominal Obesity with Incidence of Atrial Fibrillation in Heart Failure with Preserved Ejection Fraction. Curr Med Chem. 2025;32(16):3283-3294. doi: 10.2174/0929867330666230606100903.
- Saksena S, Slee A, Natale A, Lakkireddy DR, Shah D, Di Biase L, Lewalter T, Nagarakanti R, Santangeli P. Atrial Fibrillation can adversely impact Heart Failure with Preserved Ejection Fraction by its association with Heart Failure Progression and Mortality: A Post-Hoc Propensity Score-Matched Analysis of the TOPCAT Americas Trial. Europace. 2023 May 19;25(5):euad095. doi: 10.1093/europace/euad095.
- Cao Y, Guo S, Dong Y, Liu C, Zhu W. Comparison of liver fibrosis scores for predicting mortality and morbidity in heart failure with preserved ejection fraction. ESC Heart Fail. 2023 Jun;10(3):1771-1780. doi: 10.1002/ehf2.14336. Epub 2023 Mar 2.
- Curtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.
- Chen C, Zhao J, Xue R, Liu X, Zhu W, Ye M. Prognostic significance of resting cardiac power to left ventricular mass and E/e' ratio in heart failure with preserved ejection fraction. Front Cardiovasc Med. 2022 Aug 18;9:961837. doi: 10.3389/fcvm.2022.961837. eCollection 2022.
- Zhu W, Cao Y, Ye M, Huang H, Wu Y, Ma J, Dong Y, Liu X, Liu C, Lip GYH. Essen Stroke Risk Score Predicts Clinical Outcomes in Heart Failure Patients with Preserved Ejection Fraction: Evidence from the TOPCAT trial. Thromb Haemost. 2023 Jan;123(1):85-96. doi: 10.1055/a-1932-8854. Epub 2022 Aug 29.
- Zeng S, Cai X, Zheng Y, Liu X, Ye M. Associations of body mass index with mortality in heart failure with preserved ejection fraction patients with ischemic versus non-ischemic etiology. Front Cardiovasc Med. 2022 Aug 4;9:966745. doi: 10.3389/fcvm.2022.966745. eCollection 2022.
- Vaduganathan M, Ferreira JP, Rossignol P, Neuen BL, Claggett BL, Pfeffer MA, McMurray JJV, Pitt B, Zannad F, Solomon SD. Effects of steroidal mineralocorticoid receptor antagonists on acute and chronic estimated glomerular filtration rate slopes in patients with chronic heart failure. Eur J Heart Fail. 2022 Sep;24(9):1586-1590. doi: 10.1002/ejhf.2635. Epub 2022 Aug 31.
- Barkoudah E, Claggett BL, Lewis EF, O'Meara E, Clausell N, Diaz R, Fleg JL, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Prognostic Impact of Cardiovascular Versus Noncardiovascular Hospitalizations in Heart Failure With Preserved Ejection Fraction: Insights From TOPCAT. J Card Fail. 2022 Sep;28(9):1390-1397. doi: 10.1016/j.cardfail.2022.05.004. Epub 2022 May 28.
- Yang Y, Zhou Y, Cao Y, Dong Y, Liu C, Zhu W. Impact of diabetic retinopathy on prognosis of patients with heart failure with preserved ejection fraction. Nutr Metab Cardiovasc Dis. 2022 Jul;32(7):1711-1718. doi: 10.1016/j.numecd.2022.04.020. Epub 2022 Apr 27.
- Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.
- Ye M, Choy M, Liu X, Huang P, Wu Y, Dong Y, Zhu W, Liu C. Associations of BMI with mortality in HFpEF patients with concomitant diabetes with insulin versus non-insulin treatment. Diabetes Res Clin Pract. 2022 Mar;185:109805. doi: 10.1016/j.diabres.2022.109805. Epub 2022 Feb 24.
- Guo L, Liu X, Yu P, Zhu W. The "Obesity Paradox" in Patients With HFpEF With or Without Comorbid Atrial Fibrillation. Front Cardiovasc Med. 2022 Jan 11;8:743327. doi: 10.3389/fcvm.2021.743327. eCollection 2021.
- Sun J, Tai S, Guo Y, Tang L, Yang H, Li X, Xing Z, Fu L, Zhou S. Sex Differences in Characteristics and Outcomes in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Post-hoc Analysis From TOPCAT. Front Cardiovasc Med. 2021 Oct 4;8:721850. doi: 10.3389/fcvm.2021.721850. eCollection 2021.
- Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.
- Shin SH, Claggett B, Inciardi RM, Santos ABS, Shah SJ, Zile MR, Pfeffer MA, Shah AM, Solomon SD. Prognostic Value of Minimal Left Atrial Volume in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Aug 3;10(15):e019545. doi: 10.1161/JAHA.120.019545. Epub 2021 Jul 30.
- Li Y, Yu Y, Wu Y, Liang W, Dong B, Xue R, Dong Y, Zhu W, Huang P. Association of Body-Weight Fluctuation With Outcomes in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med. 2021 Jun 14;8:689591. doi: 10.3389/fcvm.2021.689591. eCollection 2021.
- Huang P, Guo Z, Liang W, Wu Y, Zhao J, He X, Zhu W, Liu C, Dong Y, Yu Y, Dong B. Weight Change and Mortality Risk in Heart Failure With Preserved Ejection Fraction. Front Cardiovasc Med. 2021 Jun 4;8:681726. doi: 10.3389/fcvm.2021.681726. eCollection 2021.
- Zhu W, Wu Y, Zhou Y, Liang W, Xue R, Wu Z, Wu D, He J, Dong Y, Liu C. Living Alone and Clinical Outcomes in Patients With Heart Failure With Preserved Ejection Fraction. Psychosom Med. 2021 Jun 1;83(5):470-476. doi: 10.1097/PSY.0000000000000945.
- Lin Y, Zhong X, Liu M, Zhang S, Xiong Z, Huang Y, Fan Y, Xu X, Guo Y, Li Y, Sun X, Zhou H, Yang D, Ye X, Liao X, Zhuang X. Risk Stratification and Efficacy of Spironolactone in Patients with Heart Failure with Preserved Ejection Fraction: Secondary Analysis of the TOPCAT Randomized Clinical Trial. Cardiovasc Drugs Ther. 2022 Apr;36(2):323-331. doi: 10.1007/s10557-021-07178-y. Epub 2021 Apr 1.
- De Marco C, Claggett BL, de Denus S, Zile MR, Huynh T, Desai AS, Sirois MG, Solomon SD, Pitt B, Rouleau JL, Pfeffer MA, O'Meara E. Impact of diabetes on serum biomarkers in heart failure with preserved ejection fraction: insights from the TOPCAT trial. ESC Heart Fail. 2021 Apr;8(2):1130-1138. doi: 10.1002/ehf2.13153. Epub 2021 Jan 12.
- Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
- Wu Y, Zhu W, He X, Xue R, Liang W, Wei F, Wu Z, Zhou Y, Wu D, He J, Dong Y, Liu C. Influence of polypharmacy on patients with heart failure with preserved ejection fraction: a retrospective analysis on adverse outcomes in the TOPCAT trial. Br J Gen Pract. 2020 Dec 28;71(702):e62-e70. doi: 10.3399/bjgp21X714245. Print 2021 Jan.
- Yang S, Troendle J. Event-specific win ratios and testing with terminal and non-terminal events. Clin Trials. 2021 Apr;18(2):180-187. doi: 10.1177/1740774520972408. Epub 2020 Nov 24.
- Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
- Zhu W, Liang W, Ye Z, Wu Y, He X, Xue R, Wu Z, Zhou Y, Zhao J, Dong Y, Liu C. Association of physical activity and risk of atrial fibrillation in heart failure with preserved ejection fraction. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):247-253. doi: 10.1016/j.numecd.2020.08.022. Epub 2020 Aug 23.
- Chandra A, Alcala MAD, Claggett B, Desai AS, Fang JC, Heitner JF, Liu J, Pitt B, Solomon SD, Pfeffer MA, Lewis EF. Associations Between Depressive Symptoms and HFpEF-Related Outcomes. JACC Heart Fail. 2020 Dec;8(12):1009-1020. doi: 10.1016/j.jchf.2020.06.010. Epub 2020 Sep 9.
- Zhu W, Wu Y, Zhou Y, Liang W, Xue R, Wu Z, Dong Y, Liu C. CHA2DS2-VASc and ATRIA Scores and Clinical Outcomes in Patients with Heart Failure with Preserved Ejection Fraction. Cardiovasc Drugs Ther. 2020 Dec;34(6):763-772. doi: 10.1007/s10557-020-07011-y.
- Cunningham JW, Vaduganathan M, Claggett BL, John JE, Desai AS, Lewis EF, Zile MR, Carson P, Jhund PS, Kober L, Pitt B, Shah SJ, Swedberg K, Anand IS, Yusuf S, McMurray JJV, Pfeffer MA, Solomon SD. Myocardial Infarction in Heart Failure With Preserved Ejection Fraction: Pooled Analysis of 3 Clinical Trials. JACC Heart Fail. 2020 Aug;8(8):618-626. doi: 10.1016/j.jchf.2020.02.007. Epub 2020 May 6.
- Flint KM, Shah SJ, Lewis EF, Kao DP. Variation in clinical and patient-reported outcomes among complex heart failure with preserved ejection fraction phenotypes. ESC Heart Fail. 2020 Jun;7(3):811-824. doi: 10.1002/ehf2.12660. Epub 2020 Mar 11.
- Myhre PL, Vaduganathan M, O'Meara E, Claggett BL, de Denus S, Jarolim P, Anand IS, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Mechanistic Effects of Spironolactone on Cardiovascular and Renal Biomarkers in Heart Failure With Preserved Ejection Fraction: A TOPCAT Biorepository Study. Circ Heart Fail. 2020 Jan;13(1):e006638. doi: 10.1161/CIRCHEARTFAILURE.119.006638. Epub 2020 Jan 20.
- Vardeny O, Claggett B, Vaduganathan M, Beldhuis I, Rouleau J, O'Meara E, Anand IS, Shah SJ, Sweitzer NK, Fang JC, Desai AS, Lewis EF, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Influence of Age on Efficacy and Safety of Spironolactone in Heart Failure. JACC Heart Fail. 2019 Dec;7(12):1022-1028. doi: 10.1016/j.jchf.2019.08.019.
- Angraal S, Mortazavi BJ, Gupta A, Khera R, Ahmad T, Desai NR, Jacoby DL, Masoudi FA, Spertus JA, Krumholz HM. Machine Learning Prediction of Mortality and Hospitalization in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 Jan;8(1):12-21. doi: 10.1016/j.jchf.2019.06.013. Epub 2019 Oct 9.
- Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
- Beale AL, Nanayakkara S, Kaye DM. Impact of Sex on Ventricular-Vascular Stiffness and Long-Term Outcomes in Heart Failure With Preserved Ejection Fraction: TOPCAT Trial Substudy. J Am Heart Assoc. 2019 Jul 2;8(13):e012190. doi: 10.1161/JAHA.119.012190. Epub 2019 Jun 22.
- Selvaraj S, Claggett B, Shah SJ, Anand IS, Rouleau JL, Desai AS, Lewis EF, Vaduganathan M, Wang SY, Pitt B, Sweitzer NK, Pfeffer MA, Solomon SD. Utility of the Cardiovascular Physical Examination and Impact of Spironolactone in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Jul;12(7):e006125. doi: 10.1161/CIRCHEARTFAILURE.119.006125. Epub 2019 Jun 21.
- Neefs J, van den Berg NWE, Krul SPJ, Boekholdt SM, de Groot JR. Effect of Spironolactone on Atrial Fibrillation in Patients with Heart Failure with Preserved Ejection Fraction: Post-Hoc Analysis of the Randomized, Placebo-Controlled TOPCAT Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):73-80. doi: 10.1007/s40256-019-00353-5.
- Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
- Merrill M, Sweitzer NK, Lindenfeld J, Kao DP. Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial. JACC Heart Fail. 2019 Mar;7(3):228-238. doi: 10.1016/j.jchf.2019.01.003.
- Myhre PL, O'Meara E, Claggett BL, de Denus S, Jarolim P, Anand IS, Beldhuis IE, Fleg JL, Lewis E, Pitt B, Rouleau JL, Solomon SD, Pfeffer MA, Desai AS. Cardiac Troponin I and Risk of Cardiac Events in Patients With Heart Failure and Preserved Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005312. doi: 10.1161/CIRCHEARTFAILURE.118.005312.
- Selvaraj S, Claggett B, Shah SJ, Anand I, Rouleau JL, O'Meara E, Desai AS, Lewis EF, Pitt B, Sweitzer NK, Fang JC, Pfeffer MA, Solomon SD. Prognostic Value of Albuminuria and Influence of Spironolactone in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Nov;11(11):e005288. doi: 10.1161/CIRCHEARTFAILURE.118.005288.
- Myhre PL, Vaduganathan M, Claggett BL, Anand IS, Sweitzer NK, Fang JC, O'Meara E, Shah SJ, Desai AS, Lewis EF, Rouleau J, Pitt B, Pfeffer MA, Solomon SD. Association of Natriuretic Peptides With Cardiovascular Prognosis in Heart Failure With Preserved Ejection Fraction: Secondary Analysis of the TOPCAT Randomized Clinical Trial. JAMA Cardiol. 2018 Oct 1;3(10):1000-1005. doi: 10.1001/jamacardio.2018.2568.
- Cikes M, Claggett B, Shah AM, Desai AS, Lewis EF, Shah SJ, Anand IS, O'Meara E, Rouleau JL, Sweitzer NK, Fang JC, Saksena S, Pitt B, Pfeffer MA, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):689-697. doi: 10.1016/j.jchf.2018.05.005. Epub 2018 Jul 11.
- Lewis EF, Claggett B, Shah AM, Liu J, Shah SJ, Anand I, O'Meara E, Sweitzer NK, Rouleau JL, Fang JC, Desai AS, Retta TM, Solomon SD, Heitner JF, Stamos TD, Boineau R, Pitt B, Pfeffer MA. Racial Differences in Characteristics and Outcomes of Patients With Heart Failure and Preserved Ejection Fraction in the Treatment of Preserved Cardiac Function Heart Failure Trial. Circ Heart Fail. 2018 Mar;11(3):e004457. doi: 10.1161/CIRCHEARTFAILURE.117.004457.
- Vaduganathan M, Claggett BL, Chatterjee NA, Anand IS, Sweitzer NK, Fang JC, O'Meara E, Shah SJ, Hegde SM, Desai AS, Lewis EF, Rouleau J, Pitt B, Pfeffer MA, Solomon SD. Sudden Death in Heart Failure With Preserved Ejection Fraction: A Competing Risks Analysis From the TOPCAT Trial. JACC Heart Fail. 2018 Aug;6(8):653-661. doi: 10.1016/j.jchf.2018.02.014. Epub 2018 Mar 4.
- Rossignol P, Claggett BL, Liu J, Vardeny O, Pitt B, Zannad F, Solomon S. Spironolactone and Resistant Hypertension in Heart Failure With Preserved Ejection Fraction. Am J Hypertens. 2018 Mar 10;31(4):407-414. doi: 10.1093/ajh/hpx210.
- Selvaraj S, Claggett B, Shah SJ, Anand I, Rouleau JL, Desai AS, Lewis EF, Pitt B, Sweitzer NK, Pfeffer MA, Solomon SD. Systolic blood pressure and cardiovascular outcomes in heart failure with preserved ejection fraction: an analysis of the TOPCAT trial. Eur J Heart Fail. 2018 Mar;20(3):483-490. doi: 10.1002/ejhf.1060. Epub 2017 Nov 16.
- Pokharel Y, Khariton Y, Tang Y, Nassif ME, Chan PS, Arnold SV, Jones PG, Spertus JA. Association of Serial Kansas City Cardiomyopathy Questionnaire Assessments With Death and Hospitalization in Patients With Heart Failure With Preserved and Reduced Ejection Fraction: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Cardiol. 2017 Dec 1;2(12):1315-1321. doi: 10.1001/jamacardio.2017.3983.
- Hegde SM, Claggett B, Shah AM, Lewis EF, Anand I, Shah SJ, Sweitzer NK, Fang JC, Pitt B, Pfeffer MA, Solomon SD. Physical Activity and Prognosis in the TOPCAT Trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist). Circulation. 2017 Sep 12;136(11):982-992. doi: 10.1161/CIRCULATIONAHA.117.028002. Epub 2017 Jun 21.
- Anand IS, Claggett B, Liu J, Shah AM, Rector TS, Shah SJ, Desai AS, O'Meara E, Fleg JL, Pfeffer MA, Pitt B, Solomon SD. Interaction Between Spironolactone and Natriuretic Peptides in Patients With Heart Failure and Preserved Ejection Fraction: From the TOPCAT Trial. JACC Heart Fail. 2017 Apr;5(4):241-252. doi: 10.1016/j.jchf.2016.11.015.
- Biering-Sorensen T, Shah SJ, Anand I, Sweitzer N, Claggett B, Liu L, Pitt B, Pfeffer MA, Solomon SD, Shah AM. Prognostic importance of left ventricular mechanical dyssynchrony in heart failure with preserved ejection fraction. Eur J Heart Fail. 2017 Aug;19(8):1043-1052. doi: 10.1002/ejhf.789. Epub 2017 Mar 21.
- Santos AB, Roca GQ, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Fang JC, Zile MR, Pitt B, Solomon SD, Shah AM. Prognostic Relevance of Left Atrial Dysfunction in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Apr;9(4):e002763. doi: 10.1161/CIRCHEARTFAILURE.115.002763.
- Joseph J, Claggett BC, Anand IS, Fleg JL, Huynh T, Desai AS, Solomon SD, O'Meara E, Mckinlay S, Pitt B, Pfeffer MA, Lewis EF. QRS Duration Is a Predictor of Adverse Outcomes in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2016 Jun;4(6):477-86. doi: 10.1016/j.jchf.2016.02.013. Epub 2016 Mar 30.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spironolactone | Small molecule | 30 mg | Oral |
| Subject | Spironolactone | Small molecule | 45 mg | Oral |