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Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial.
Circ Heart Fail. 2013 Mar; 6(2):184-92.CH

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.

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+Show Affiliations

Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA. sanjiv.shah@northwestern.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

23258572

Citation

Shah, Sanjiv J., et al. "Baseline Characteristics of Patients in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial." Circulation. Heart Failure, vol. 6, no. 2, 2013, pp. 184-92.
Shah SJ, Heitner JF, Sweitzer NK, et al. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail. 2013;6(2):184-92.
Shah, S. J., Heitner, J. F., Sweitzer, N. K., Anand, I. S., Kim, H. Y., Harty, B., Boineau, R., Clausell, N., Desai, A. S., Diaz, R., Fleg, J. L., Gordeev, I., Lewis, E. F., Markov, V., O'Meara, E., Kobulia, B., Shaburishvili, T., Solomon, S. D., Pitt, B., ... Li, R. (2013). Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circulation. Heart Failure, 6(2), 184-92. https://doi.org/10.1161/CIRCHEARTFAILURE.112.972794
Shah SJ, et al. Baseline Characteristics of Patients in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial. Circ Heart Fail. 2013;6(2):184-92. PubMed PMID: 23258572.
* Article titles in AMA citation format should be in sentence-case
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, Y1 - 2012/12/20/ PY - 2012/12/22/entrez PY - 2012/12/22/pubmed PY - 2013/5/10/medline SP - 184 EP - 92 JF - Circulation. Heart failure JO - Circ Heart Fail VL - 6 IS - 2 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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. UNIQUE IDENTIFIER: NCT00094302. SN - 1941-3297 UR - https://www.unboundmedicine.com/medline/citation/23258572/Baseline_characteristics_of_patients_in_the_treatment_of_preserved_cardiac_function_heart_failure_with_an_aldosterone_antagonist_trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCHEARTFAILURE.112.972794?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -