• Sanjiv J Shah, John F Heitner, Nancy K Sweitzer, Inder S Anand, Hae-Young Kim, Brian Harty, Robin Boineau, Nadine Clausell, Akshay S Desai, Rafael Diaz, Jerome L Fleg, Ivan Gordeev, Eldrin F Lewis, Valetin Markov, Eileen O'Meara, Bondo Kobulia, Tamaz Shaburishvili, Scott D Solomon, Bertram Pitt, Marc A Pfeffer, and Rebecca Li.
• Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. sanjiv.shah@northwestern.edu
• Circ Heart Fail. 2013 Mar 1;6(2):184-92.

BackgroundTreatment 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 ResultsBetween 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%.ConclusionsTOPCAT 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 RegistrationURL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302.

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