BACKGROUND: Treatment of Preserved Cardiac Function with an Aldosterone Antagonist (TOPCAT) is an ongoing randomized controlled trial of spironolactone versus placebo for heart failure with preserved ejection fraction (HFpEF). We sought to describe the baseline clinical characteristics of subjects enrolled inTOPCAT relative to other contemporary observational studies and randomized clinical trials of HFpEF. METHODS AND RESULTS:Between August 2006 and January 2012, 3445 patients with symptomatic HFpEF from 270 sites in 6 countries were enrolled in TOPCAT. At the baseline study visit, all subjects provided a detailed medical history and underwent physical examination, electrocardiography, quality of life, and laboratory assessment. Key parameters were compared with other large, contemporary HFpEF studies. The mean age was 68.6±9.6 years with a slight female predominance (52%); mean body mass index was 32 kg/m2; and comorbidities were common. History of hypertension (91% prevalence in TOPCAT) exceeded all other major HFpEF clinical trials. However, baseline blood pressure was well controlled (129/76 mm Hg; systolic blood pressure 7-16 mm Hg lower than other similar trials). Other common comorbidities included coronary artery disease (57%), atrial fibrillation (35%), chronic kidney disease (38%) and diabetes mellitus (32%). Self-reported activity levels were low, quality of life scores were comparable with those reported for patients with end-stage renal disease, and the prevalence of moderate or greater depression was 27%. CONCLUSIONS:TOPCAT subjects share many common characteristics with contemporary HFpEF cohorts. Low activity level, significantly decreased quality of life, and depression were common at baseline in TOPCAT, underscoring the continued unmet need for evidence-based treatment strategies in HFpEF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302.
RCT Entities:
BACKGROUND: Treatment of Preserved Cardiac Function with an Aldosterone Antagonist (TOPCAT) is an ongoing randomized controlled trial of spironolactone versus placebo for heart failure with preserved ejection fraction (HFpEF). We sought to describe the baseline clinical characteristics of subjects enrolled in TOPCAT relative to other contemporary observational studies and randomized clinical trials of HFpEF. METHODS AND RESULTS: Between August 2006 and January 2012, 3445 patients with symptomatic HFpEF from 270 sites in 6 countries were enrolled in TOPCAT. At the baseline study visit, all subjects provided a detailed medical history and underwent physical examination, electrocardiography, quality of life, and laboratory assessment. Key parameters were compared with other large, contemporary HFpEF studies. The mean age was 68.6±9.6 years with a slight female predominance (52%); mean body mass index was 32 kg/m2; and comorbidities were common. History of hypertension (91% prevalence in TOPCAT) exceeded all other major HFpEF clinical trials. However, baseline blood pressure was well controlled (129/76 mm Hg; systolic blood pressure 7-16 mm Hg lower than other similar trials). Other common comorbidities included coronary artery disease (57%), atrial fibrillation (35%), chronic kidney disease (38%) and diabetes mellitus (32%). Self-reported activity levels were low, quality of life scores were comparable with those reported for patients with end-stage renal disease, and the prevalence of moderate or greater depression was 27%. CONCLUSIONS: TOPCAT subjects share many common characteristics with contemporary HFpEF cohorts. Low activity level, significantly decreased quality of life, and depression were common at baseline in TOPCAT, underscoring the continued unmet need for evidence-based treatment strategies in HFpEF. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302.
Authors: Dalane W Kitzman; William C Little; Peter H Brubaker; Roger T Anderson; W Gregory Hundley; Christian T Marburger; Bridget Brosnihan; Timothy M Morgan; Kathryn P Stewart Journal: JAMA Date: 2002-11-06 Impact factor: 56.272
Authors: John S Gottdiener; Robyn L McClelland; Robert Marshall; Lynn Shemanski; Curt D Furberg; Dalane W Kitzman; Mary Cushman; Joseph Polak; Julius M Gardin; Bernard J Gersh; Gerard P Aurigemma; Teri A Manolio Journal: Ann Intern Med Date: 2002-10-15 Impact factor: 25.391
Authors: Bertram Pitt; Willem Remme; Faiez Zannad; James Neaton; Felipe Martinez; Barbara Roniker; Richard Bittman; Steve Hurley; Jay Kleiman; Marjorie Gatlin Journal: N Engl J Med Date: 2003-03-31 Impact factor: 91.245
Authors: Philip M Mottram; Brian Haluska; Rodel Leano; Diane Cowley; Michael Stowasser; Thomas H Marwick Journal: Circulation Date: 2004-07-26 Impact factor: 29.690
Authors: Salim Yusuf; Marc A Pfeffer; Karl Swedberg; Christopher B Granger; Peter Held; John J V McMurray; Eric L Michelson; Bertil Olofsson; Jan Ostergren Journal: Lancet Date: 2003-09-06 Impact factor: 79.321
Authors: J McMurray; J Ostergren; M Pfeffer; K Swedberg; C Granger; S Yusuf; P Held; E Michelson; B Olofsson Journal: Eur J Heart Fail Date: 2003-06 Impact factor: 15.534
Authors: Jennifer E Ho; Emily K Zern; Luke Wooster; Cole S Bailey; Thomas Cunningham; Aaron S Eisman; Kathryn M Hardin; Giovanna A Zampierollo; Petr Jarolim; Paul P Pappagianopoulos; Rajeev Malhotra; Matthew Nayor; Gregory D Lewis Journal: Circulation Date: 2019-05-28 Impact factor: 29.690
Authors: Angela B S Santos; Gabriela Querejeta Roca; Brian Claggett; Nancy K Sweitzer; Sanjiv J Shah; Inder S Anand; James C Fang; Michael R Zile; Bertram Pitt; Scott D Solomon; Amil M Shah Journal: Circ Heart Fail Date: 2016-04 Impact factor: 8.790
Authors: Rebecca J Cogswell; Faye L Norby; Rebecca F Gottesman; Lin Y Chen; Scott Solomon; Amil Shah; Alvaro Alonso Journal: Eur J Heart Fail Date: 2017-07-24 Impact factor: 15.534
Authors: Michael R Zile; Catalin F Baicu; John S Ikonomidis; Robert E Stroud; Paul J Nietert; Amy D Bradshaw; Rebecca Slater; Bradley M Palmer; Peter Van Buren; Markus Meyer; Margaret M Redfield; David A Bull; Henk L Granzier; Martin M LeWinter Journal: Circulation Date: 2015-01-30 Impact factor: 29.690
Authors: Fouad A Zouein; Lisandra E de Castro Brás; Danielle V da Costa; Merry L Lindsey; Mazen Kurdi; George W Booz Journal: J Cardiovasc Pharmacol Date: 2013-07 Impact factor: 3.105