Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial

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 & 1 others Rebecca Li

Research output: Contribution to journalArticle

98 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)184-192
Number of pages9
JournalCirculation: Heart Failure
Volume6
Issue number2
DOIs
StatePublished - Mar 2013
Externally publishedYes

Fingerprint

Mineralocorticoid Receptor Antagonists
Heart Failure
Quality of Life
Blood Pressure
Therapeutics
Comorbidity
Randomized Controlled Trials
Spironolactone
Chronic Renal Insufficiency
Atrial Fibrillation
Physical Examination
Chronic Kidney Failure
Observational Studies
Coronary Artery Disease
Diabetes Mellitus
Electrocardiography
Body Mass Index
Placebos
Clinical Trials
Hypertension

Keywords

  • Aldosterone
  • Diastolic heart failure
  • Mineralocorticoid receptor
  • Randomized controlled trial
  • Spironolactone

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Medicine(all)

Cite this

Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. / Shah, Sanjiv J.; Heitner, John F.; Sweitzer, Nancy K; Anand, Inder S.; Kim, Hae Young; Harty, Brian; Boineau, Robin; Clausell, Nadine; Desai, Akshay S.; Diaz, Rafael; Fleg, Jerome L.; Gordeev, Ivan; Lewis, Eldrin F.; Markov, Valetin; O'Meara, Eileen; Kobulia, Bondo; Shaburishvili, Tamaz; Solomon, Scott D.; Pitt, Bertram; Pfeffer, Marc A.; Li, Rebecca.

In: Circulation: Heart Failure, Vol. 6, No. 2, 03.2013, p. 184-192.

Research output: Contribution to journalArticle

Shah, SJ, Heitner, JF, Sweitzer, NK, Anand, IS, Kim, HY, Harty, B, Boineau, R, Clausell, N, Desai, AS, Diaz, R, Fleg, JL, Gordeev, I, Lewis, EF, Markov, V, O'Meara, E, Kobulia, B, Shaburishvili, T, Solomon, SD, Pitt, B, Pfeffer, MA & Li, R 2013, '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, pp. 184-192. https://doi.org/10.1161/CIRCHEARTFAILURE.112.972794
Shah, Sanjiv J. ; Heitner, John F. ; Sweitzer, Nancy K ; Anand, Inder S. ; Kim, Hae Young ; Harty, Brian ; Boineau, Robin ; Clausell, Nadine ; Desai, Akshay S. ; Diaz, Rafael ; Fleg, Jerome L. ; Gordeev, Ivan ; Lewis, Eldrin F. ; Markov, Valetin ; O'Meara, Eileen ; Kobulia, Bondo ; Shaburishvili, Tamaz ; Solomon, Scott D. ; Pitt, Bertram ; Pfeffer, Marc A. ; Li, Rebecca. / Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. In: Circulation: Heart Failure. 2013 ; Vol. 6, No. 2. pp. 184-192.
@article{8fd4f654f27b48269dd780e8690f1b32,
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. 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.",
keywords = "Aldosterone, Diastolic heart failure, Mineralocorticoid receptor, Randomized controlled trial, Spironolactone",
author = "Shah, {Sanjiv J.} and Heitner, {John F.} and Sweitzer, {Nancy K} and Anand, {Inder S.} and Kim, {Hae Young} and Brian Harty and Robin Boineau and Nadine Clausell and Desai, {Akshay S.} and Rafael Diaz and Fleg, {Jerome L.} and Ivan Gordeev and Lewis, {Eldrin F.} and Valetin Markov and Eileen O'Meara and Bondo Kobulia and Tamaz Shaburishvili and Solomon, {Scott D.} and Bertram Pitt and Pfeffer, {Marc A.} and Rebecca Li",
year = "2013",
month = "3",
doi = "10.1161/CIRCHEARTFAILURE.112.972794",
language = "English (US)",
volume = "6",
pages = "184--192",
journal = "Circulation: Heart Failure",
issn = "1941-3297",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

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

Y1 - 2013/3

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

UR - http://www.scopus.com/inward/record.url?scp=84877259591&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84877259591&partnerID=8YFLogxK

U2 - 10.1161/CIRCHEARTFAILURE.112.972794

DO - 10.1161/CIRCHEARTFAILURE.112.972794

M3 - Article

VL - 6

SP - 184

EP - 192

JO - Circulation: Heart Failure

JF - Circulation: Heart Failure

SN - 1941-3297

IS - 2

ER -