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Volumn 14, Issue 4, 2017, Pages 217-222

Designing Future Clinical Trials in Heart Failure With Preserved Ejection Fraction: Lessons From TOPCAT

Author keywords

Clinical trials; Heart failure with preserved ejection fraction; International variation; Mineralocorticoid receptor antagonists; Spironolactone; Study design

Indexed keywords

BIOLOGICAL MARKER; MINERALOCORTICOID ANTAGONIST; SPIRONOLACTONE; DIURETIC AGENT;

EID: 85021250142     PISSN: 15469530     EISSN: 15469549     Source Type: Journal    
DOI: 10.1007/s11897-017-0336-x     Document Type: Review
Times cited : (13)

References (35)
  • 1
    • 84896961871 scopus 로고    scopus 로고
    • The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries
    • PID: 24491689
    • Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, et al. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014;63(12):1123–33. doi:10.1016/j.jacc.2013.11.053.
    • (2014) J Am Coll Cardiol , vol.63 , Issue.12 , pp. 1123-1133
    • Ambrosy, A.P.1    Fonarow, G.C.2    Butler, J.3    Chioncel, O.4    Greene, S.J.5    Vaduganathan, M.6
  • 2
    • 84856206230 scopus 로고    scopus 로고
    • Serum aldosterone and its relationship to left ventricular structure and geometry in patients with preserved left ventricular ejection fraction
    • COI: 1:CAS:528:DC%2BC38XhtVCns70%3D, PID: 21856682
    • Edelmann F, Tomaschitz A, Wachter R, Gelbrich G, Knoke M, Dungen HD, et al. Serum aldosterone and its relationship to left ventricular structure and geometry in patients with preserved left ventricular ejection fraction. Eur Heart J. 2012;33(2):203–12. doi:10.1093/eurheartj/ehr292.
    • (2012) Eur Heart J , vol.33 , Issue.2 , pp. 203-212
    • Edelmann, F.1    Tomaschitz, A.2    Wachter, R.3    Gelbrich, G.4    Knoke, M.5    Dungen, H.D.6
  • 3
    • 0035818917 scopus 로고    scopus 로고
    • Aldosterone in congestive heart failure
    • COI: 1:CAS:528:DC%2BD3MXovFKjtbw%3D, PID: 11759649
    • Weber KT. Aldosterone in congestive heart failure. N Engl J Med. 2001;345(23):1689–97. doi:10.1056/NEJMra000050.
    • (2001) N Engl J Med , vol.345 , Issue.23 , pp. 1689-1697
    • Weber, K.T.1
  • 4
    • 85030124629 scopus 로고    scopus 로고
    • ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017; doi:10.1016/j.jacc.2017.04.025
    • •• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, et al. 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017; doi:10.1016/j.jacc.2017.04.025. The updated 2017 ACC/AHA/HFSA clinical practice guidelines for the management of patients with HF.
    • (2017) The updated 2017 ACC/AHA/HFSA clinical practice guidelines for the management of patients with HF
    • Yancy1    Cw, J.M.2    Bozkurt, B.3    Butler, J.4    Casey, D.E.5    Colvin, M.M.6
  • 5
    • 84874367056 scopus 로고    scopus 로고
    • Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial
    • COI: 1:CAS:528:DC%2BC3sXjsFCrsbs%3D, PID: 23443441
    • Edelmann F, Wachter R, Schmidt AG, Kraigher-Krainer E, Colantonio C, Kamke W, et al. Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: the Aldo-DHF randomized controlled trial. JAMA. 2013;309(8):781–91. doi:10.1001/jama.2013.905.
    • (2013) JAMA , vol.309 , Issue.8 , pp. 781-791
    • Edelmann, F.1    Wachter, R.2    Schmidt, A.G.3    Kraigher-Krainer, E.4    Colantonio, C.5    Kamke, W.6
  • 6
    • 79960984168 scopus 로고    scopus 로고
    • Results of the randomized aldosterone antagonism in heart failure with preserved ejection fraction trial (RAAM-PEF)
    • PID: 21807324
    • Deswal A, Richardson P, Bozkurt B, Mann DL. Results of the randomized aldosterone antagonism in heart failure with preserved ejection fraction trial (RAAM-PEF). J Card Fail. 2011;17(8):634–42. doi:10.1016/j.cardfail.2011.04.007.
    • (2011) J Card Fail , vol.17 , Issue.8 , pp. 634-642
    • Deswal, A.1    Richardson, P.2    Bozkurt, B.3    Mann, D.L.4
  • 7
    • 85006189685 scopus 로고    scopus 로고
    • Effect of mineralocorticoid receptor antagonists on cardiac structure and function in patients with diastolic dysfunction and heart failure with preserved ejection fraction: a meta-analysis and systematic review
    • PID: 26459931
    • Pandey A, Garg S, Matulevicius SA, Shah AM, Garg J, Drazner MH, et al. Effect of mineralocorticoid receptor antagonists on cardiac structure and function in patients with diastolic dysfunction and heart failure with preserved ejection fraction: a meta-analysis and systematic review. J Am Heart Assoc. 2015;4(10):e002137. doi:10.1161/JAHA.115.002137.
    • (2015) J Am Heart Assoc , vol.4 , Issue.10
    • Pandey, A.1    Garg, S.2    Matulevicius, S.A.3    Shah, A.M.4    Garg, J.5    Drazner, M.H.6
  • 8
    • 84898713808 scopus 로고    scopus 로고
    • Spironolactone for heart failure with preserved ejection fraction
    • COI: 1:CAS:528:DC%2BC2cXmsVWruro%3D, PID: 24716680, The TOPCAT trial, a phase 3, international, double-blind, placebo-controlled trial of spironolactonepatients with HFpEF
    • •• Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014;370(15):1383–92. doi:10.1056/NEJMoa1313731. The TOPCAT trial, a phase 3, international, double-blind, placebo-controlled trial of spironolactone in patients with HFpEF.
    • (2014) N Engl J Med , vol.370 , Issue.15 , pp. 1383-1392
    • Pitt, B.1    Pfeffer, M.A.2    Assmann, S.F.3    Boineau, R.4    Anand, I.S.5    Claggett, B.6
  • 9
    • 84925581450 scopus 로고    scopus 로고
    • Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial
    • COI: 1:CAS:528:DC%2BC2MXnslShtQ%3D%3D, PID: 25406305, The pre-specified region-specific subgroup analysis of the TOPCAT trial demonstrated marked global heterogeneityclinical profiles, event rates,response to spironolactone
    • •• Pfeffer MA, Claggett B, Assmann SF, Boineau R, Anand IS, Clausell N, et al. Regional variation in patients and outcomes in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial. Circulation. 2015;131(1):34–42. doi:10.1161/CIRCULATIONAHA.114.013255. The pre-specified region-specific subgroup analysis of the TOPCAT trial demonstrated marked global heterogeneity in clinical profiles, event rates, and response to spironolactone.
    • (2015) Circulation , vol.131 , Issue.1 , pp. 34-42
    • Pfeffer, M.A.1    Claggett, B.2    Assmann, S.F.3    Boineau, R.4    Anand, I.S.5    Clausell, N.6
  • 10
    • 85018939774 scopus 로고    scopus 로고
    • Spironolactone metabolites in TOPCAT—new insights into regional variation
    • PID: 28445660
    • de Denus S, O’Meara E, Desai AS, Claggett B, Lewis EF, Leclair G, et al. Spironolactone metabolites in TOPCAT—new insights into regional variation. N Engl J Med. 2017;376(17):1690–2. doi:10.1056/NEJMc1612601.
    • (2017) N Engl J Med , vol.376 , Issue.17 , pp. 1690-1692
    • de Denus, S.1    O’Meara, E.2    Desai, A.S.3    Claggett, B.4    Lewis, E.F.5    Leclair, G.6
  • 12
    • 84941802525 scopus 로고    scopus 로고
    • Geographic differences in heart failure trials
    • PID: 26198782
    • Ferreira JP, Girerd N, Rossignol P, Zannad F. Geographic differences in heart failure trials. Eur J Heart Fail. 2015;17(9):893–905. doi:10.1002/ejhf.326.
    • (2015) Eur J Heart Fail , vol.17 , Issue.9 , pp. 893-905
    • Ferreira, J.P.1    Girerd, N.2    Rossignol, P.3    Zannad, F.4
  • 13
    • 85010430707 scopus 로고    scopus 로고
    • Detection and management of geographic disparities in the TOPCAT trial: lessons learned and derivative recommendations
    • PID: 27747305
    • Bristow MR, Enciso JS, Gersh BJ, Grady C, Rice MM, Singh S, et al. Detection and management of geographic disparities in the TOPCAT trial: lessons learned and derivative recommendations. JACC Basic Transl Sci. 2016;1(3):180–9. doi:10.1016/j.jacbts.2016.03.001.
    • (2016) JACC Basic Transl Sci , vol.1 , Issue.3 , pp. 180-189
    • Bristow, M.R.1    Enciso, J.S.2    Gersh, B.J.3    Grady, C.4    Rice, M.M.5    Singh, S.6
  • 14
    • 84941802131 scopus 로고    scopus 로고
    • Same protocol, different continents, different patients: should we continue to conduct global heart failure trials?
    • PID: 26289544
    • Greene SJ, Gheorghiade M. Same protocol, different continents, different patients: should we continue to conduct global heart failure trials? Eur J Heart Fail. 2015;17(9):875–8. doi:10.1002/ejhf.335.
    • (2015) Eur J Heart Fail , vol.17 , Issue.9 , pp. 875-878
    • Greene, S.J.1    Gheorghiade, M.2
  • 16
    • 84896726059 scopus 로고    scopus 로고
    • Site selection in global clinical trials in patients hospitalized for heart failure: perceived problems and potential solutions
    • COI: 1:CAS:528:DC%2BC2cXivFensb0%3D, PID: 23099992
    • Gheorghiade M, Vaduganathan M, Greene SJ, Mentz RJ, Adams KF Jr, Anker SD, et al. Site selection in global clinical trials in patients hospitalized for heart failure: perceived problems and potential solutions. Heart Fail Rev. 2014;19(2):135–52. doi:10.1007/s10741-012-9361-8.
    • (2014) Heart Fail Rev , vol.19 , Issue.2 , pp. 135-152
    • Gheorghiade, M.1    Vaduganathan, M.2    Greene, S.J.3    Mentz, R.J.4    Adams, K.F.5    Anker, S.D.6
  • 18
    • 84928041834 scopus 로고    scopus 로고
    • Patient selection in heart failure with preserved ejection fraction clinical trials
    • PID: 25908073
    • Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, et al. Patient selection in heart failure with preserved ejection fraction clinical trials. J Am Coll Cardiol. 2015;65(16):1668–82. doi:10.1016/j.jacc.2015.03.043.
    • (2015) J Am Coll Cardiol , vol.65 , Issue.16 , pp. 1668-1682
    • Kelly, J.P.1    Mentz, R.J.2    Mebazaa, A.3    Voors, A.A.4    Butler, J.5    Roessig, L.6
  • 19
    • 84865527834 scopus 로고    scopus 로고
    • Prevalence, clinical phenotype, and outcomes associated with normal B-type natriuretic peptide levels in heart failure with preserved ejection fraction
    • COI: 1:CAS:528:DC%2BC38XosVKitL4%3D, PID: 22681864
    • Anjan VY, Loftus TM, Burke MA, Akhter N, Fonarow GC, Gheorghiade M, et al. Prevalence, clinical phenotype, and outcomes associated with normal B-type natriuretic peptide levels in heart failure with preserved ejection fraction. Am J Cardiol. 2012;110(6):870–6. doi:10.1016/j.amjcard.2012.05.014.
    • (2012) Am J Cardiol , vol.110 , Issue.6 , pp. 870-876
    • Anjan, V.Y.1    Loftus, T.M.2    Burke, M.A.3    Akhter, N.4    Fonarow, G.C.5    Gheorghiade, M.6
  • 20
    • 84991694106 scopus 로고    scopus 로고
    • Influence of atrial fibrillation on post-discharge natriuretic peptide trajectory and clinical outcomes among patients hospitalized for heart failure: insights from the ASTRONAUT trial
    • COI: 1:CAS:528:DC%2BC2sXltlyjsL0%3D, PID: 27748006
    • Greene SJ, Fonarow GC, Solomon SD, Subacius HP, Ambrosy AP, Vaduganathan M, et al. Influence of atrial fibrillation on post-discharge natriuretic peptide trajectory and clinical outcomes among patients hospitalized for heart failure: insights from the ASTRONAUT trial. Eur J Heart Fail. 2017;19(4):552–62. doi:10.1002/ejhf.674.
    • (2017) Eur J Heart Fail , vol.19 , Issue.4 , pp. 552-562
    • Greene, S.J.1    Fonarow, G.C.2    Solomon, S.D.3    Subacius, H.P.4    Ambrosy, A.P.5    Vaduganathan, M.6
  • 21
    • 85006241352 scopus 로고    scopus 로고
    • Atrial fibrillation in heart failure with preserved ejection fraction: insights into mechanisms and therapeutics
    • Patel RB, Vaduganathan M, Shah SJ, Butler J. Atrial fibrillation in heart failure with preserved ejection fraction: insights into mechanisms and therapeutics. Pharmacol Ther. 2016; doi:10.1016/j.pharmthera.2016.10.019.
    • (2016) Pharmacol Ther
    • Patel, R.B.1    Vaduganathan, M.2    Shah, S.J.3    Butler, J.4
  • 22
    • 84954194783 scopus 로고    scopus 로고
    • Spectrum of epidemiological and clinical findings in patients with heart failure with preserved ejection fraction stratified by study design: a systematic review
    • PID: 26634799
    • Vaduganathan M, Michel A, Hall K, Mulligan C, Nodari S, Shah SJ, et al. Spectrum of epidemiological and clinical findings in patients with heart failure with preserved ejection fraction stratified by study design: a systematic review. Eur J Heart Fail. 2016;18(1):54–65. doi:10.1002/ejhf.442.
    • (2016) Eur J Heart Fail , vol.18 , Issue.1 , pp. 54-65
    • Vaduganathan, M.1    Michel, A.2    Hall, K.3    Mulligan, C.4    Nodari, S.5    Shah, S.J.6
  • 23
    • 85016578062 scopus 로고    scopus 로고
    • Interaction between spironolactone and natriuretic peptides in patients with heart failure and preserved ejection fraction: from the TOPCAT trial
    • PID: 28359411
    • Anand IS, Claggett B, Liu J, Shah AM, Rector TS, Shah SJ, et al. Interaction between spironolactone and natriuretic peptides in patients with heart failure and preserved ejection fraction: from the TOPCAT trial. JACC Heart Fail. 2017;5(4):241–52. doi:10.1016/j.jchf.2016.11.015.
    • (2017) JACC Heart Fail , vol.5 , Issue.4 , pp. 241-252
    • Anand, I.S.1    Claggett, B.2    Liu, J.3    Shah, A.M.4    Rector, T.S.5    Shah, S.J.6
  • 24
    • 84949524331 scopus 로고    scopus 로고
    • Role of biomarkers in cardiac structure phenotyping in heart failure with preserved ejection fraction: critical appraisal and practical use
    • PID: 26493383
    • D’Elia E, Vaduganathan M, Gori M, Gavazzi A, Butler J, Senni M. Role of biomarkers in cardiac structure phenotyping in heart failure with preserved ejection fraction: critical appraisal and practical use. Eur J Heart Fail. 2015;17(12):1231–9. doi:10.1002/ejhf.430.
    • (2015) Eur J Heart Fail , vol.17 , Issue.12 , pp. 1231-1239
    • D’Elia, E.1    Vaduganathan, M.2    Gori, M.3    Gavazzi, A.4    Butler, J.5    Senni, M.6
  • 25
    • 77957907689 scopus 로고    scopus 로고
    • Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction
    • PID: 20543134
    • Borlaug BA, Nishimura RA, Sorajja P, Lam CS, Redfield MM. Exercise hemodynamics enhance diagnosis of early heart failure with preserved ejection fraction. Circ Heart Fail. 2010;3(5):588–95. doi:10.1161/CIRCHEARTFAILURE.109.930701.
    • (2010) Circ Heart Fail , vol.3 , Issue.5 , pp. 588-595
    • Borlaug, B.A.1    Nishimura, R.A.2    Sorajja, P.3    Lam, C.S.4    Redfield, M.M.5
  • 26
    • 84893321088 scopus 로고    scopus 로고
    • Impaired systolic function by strain imaging in heart failure with preserved ejection fraction
    • PID: 24184245
    • Kraigher-Krainer E, Shah AM, Gupta DK, Santos A, Claggett B, Pieske B, et al. Impaired systolic function by strain imaging in heart failure with preserved ejection fraction. J Am Coll Cardiol. 2014;63(5):447–56. doi:10.1016/j.jacc.2013.09.052.
    • (2014) J Am Coll Cardiol , vol.63 , Issue.5 , pp. 447-456
    • Kraigher-Krainer, E.1    Shah, A.M.2    Gupta, D.K.3    Santos, A.4    Claggett, B.5    Pieske, B.6
  • 27
    • 84927626763 scopus 로고    scopus 로고
    • Phenomapping for novel classification of heart failure with preserved ejection fraction
    • PID: 25398313
    • Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, et al. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015;131(3):269–79. doi:10.1161/CIRCULATIONAHA.114.010637.
    • (2015) Circulation , vol.131 , Issue.3 , pp. 269-279
    • Shah, S.J.1    Katz, D.H.2    Selvaraj, S.3    Burke, M.A.4    Yancy, C.W.5    Gheorghiade, M.6
  • 29
    • 85026307373 scopus 로고    scopus 로고
    • Comparison of approaches for heart failure case identification from electronic health record data
    • PID: 27706470
    • Blecker S, Katz SD, Horwitz LI, Kuperman G, Park H, Gold A, et al. Comparison of approaches for heart failure case identification from electronic health record data. JAMA Cardiol. 2016;1(9):1014–20. doi:10.1001/jamacardio.2016.3236.
    • (2016) JAMA Cardiol , vol.1 , Issue.9 , pp. 1014-1020
    • Blecker, S.1    Katz, S.D.2    Horwitz, L.I.3    Kuperman, G.4    Park, H.5    Gold, A.6
  • 31
    • 84978064544 scopus 로고    scopus 로고
    • Adaptive designs for clinical trials
    • PID: 27406349
    • Bhatt DL, Mehta C. Adaptive designs for clinical trials. N Engl J Med. 2016;375(1):65–74. doi:10.1056/NEJMra1510061.
    • (2016) N Engl J Med , vol.375 , Issue.1 , pp. 65-74
    • Bhatt, D.L.1    Mehta, C.2
  • 32
    • 84994058196 scopus 로고    scopus 로고
    • Treatment of heart failure with preserved ejection fraction: reflections on its treatment with an aldosterone antagonist
    • PID: 27437645
    • Pfeffer MA, Braunwald E. Treatment of heart failure with preserved ejection fraction: reflections on its treatment with an aldosterone antagonist. JAMA Cardiol. 2016;1(1):7–8. doi:10.1001/jamacardio.2015.0356.
    • (2016) JAMA Cardiol , vol.1 , Issue.1 , pp. 7-8
    • Pfeffer, M.A.1    Braunwald, E.2
  • 33
    • 84942808428 scopus 로고    scopus 로고
    • Spironolactone for management of heart failure with preserved ejection fraction: whither to after TOPCAT?
    • PID: 26408016
    • Mitter SS, Shah SJ. Spironolactone for management of heart failure with preserved ejection fraction: whither to after TOPCAT? Curr Atheroscler Rep. 2015;17(11):64. doi:10.1007/s11883-015-0541-6.
    • (2015) Curr Atheroscler Rep , vol.17 , Issue.11 , pp. 64
    • Mitter, S.S.1    Shah, S.J.2
  • 35
    • 84955481124 scopus 로고    scopus 로고
    • Sharing clinical trial data—a proposal from the International Committee of Medical Journal Editors
    • PID: 26786954
    • Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data—a proposal from the International Committee of Medical Journal Editors. N Engl J Med. 2016;374(4):384–6. doi:10.1056/NEJMe1515172.
    • (2016) N Engl J Med , vol.374 , Issue.4 , pp. 384-386
    • Taichman, D.B.1    Backus, J.2    Baethge, C.3    Bauchner, H.4    de Leeuw, P.W.5    Drazen, J.M.6


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