title: Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial.
abstract: 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.
  
  
  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.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302.
authors.affiliation: Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. sanjiv.shah@northwestern.edu
authors.forename: Sanjiv J
authors.initials: SJ
authors.lastname: Shah
authors.forename: John F
authors.initials: JF
authors.lastname: Heitner
authors.forename: Nancy K
authors.initials: NK
authors.lastname: Sweitzer
authors.forename: Inder S
authors.initials: IS
authors.lastname: Anand
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Brian
authors.initials: B
authors.lastname: Harty
authors.forename: Robin
authors.initials: R
authors.lastname: Boineau
authors.forename: Nadine
authors.initials: N
authors.lastname: Clausell
authors.forename: Akshay S
authors.initials: AS
authors.lastname: Desai
authors.forename: Rafael
authors.initials: R
authors.lastname: Diaz
authors.forename: Jerome L
authors.initials: JL
authors.lastname: Fleg
authors.forename: Ivan
authors.initials: I
authors.lastname: Gordeev
authors.forename: Eldrin F
authors.initials: EF
authors.lastname: Lewis
authors.forename: Valetin
authors.initials: V
authors.lastname: Markov
authors.forename: Eileen
authors.initials: E
authors.lastname: O'Meara
authors.forename: Bondo
authors.initials: B
authors.lastname: Kobulia
authors.forename: Tamaz
authors.initials: T
authors.lastname: Shaburishvili
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.forename: Rebecca
authors.initials: R
authors.lastname: Li
mesh_terms: D000368:Aged; D001118:Argentina / Q000453:epidemiology; D015897:Comorbidity; D003863:Depression / Q000453:epidemiology; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D006801:Humans; D008019:Life Style; D008297:Male; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000627:therapeutic use*; D010808:Physical Examination; D011237:Predictive Value of Tests; D011788:Quality of Life; D013148:Spironolactone / Q000627:therapeutic use*; D013318:Stroke Volume; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014586:USSR / Q000453:epidemiology; D014481:United States / Q000453:epidemiology
chemical_list: D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone