TY - JOUR
T1 - Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial
AU - Shah, Sanjiv J.
AU - Heitner, John F.
AU - Sweitzer, Nancy K.
AU - Anand, Inder S.
AU - Kim, Hae Young
AU - Harty, Brian
AU - Boineau, Robin
AU - Clausell, Nadine
AU - Desai, Akshay S.
AU - Diaz, Rafael
AU - Fleg, Jerome L.
AU - Gordeev, Ivan
AU - Lewis, Eldrin F.
AU - Markov, Valetin
AU - O'Meara, Eileen
AU - Kobulia, Bondo
AU - Shaburishvili, Tamaz
AU - Solomon, Scott D.
AU - Pitt, Bertram
AU - Pfeffer, Marc A.
AU - Li, Rebecca
PY - 2013/3/1
Y1 - 2013/3/1
N2 - 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.
AB - 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.
KW - Aldosterone
KW - Diastolic heart failure
KW - Mineralocorticoid receptor
KW - Randomized controlled trial
KW - Spironolactone
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U2 - 10.1161/CIRCHEARTFAILURE.112.972794
DO - 10.1161/CIRCHEARTFAILURE.112.972794
M3 - Article
C2 - 23258572
AN - SCOPUS:84877259591
SN - 1941-3289
VL - 6
SP - 184
EP - 192
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
IS - 2
ER -