Patient Selection in Heart Failure With Preserved Ejection Fraction Clinical Trials

被引：116

作者：

Kelly, Jacob P. ^{[1
]}

Mentz, Robert J. ^{[1
]}

Mebazaa, Alexandre ^{[2
]}

Voors, Adriaan A. ^{[3
]}

Butler, Javed ^{[4
]}

Roessig, Lothar ^{[5
]}

Fiuzat, Mona ^{[1
]}

Zannad, Faiez ^{[6
,7
]}

Pitt, Bertram ^{[8
]}

O'Connor, Christopher M. ^{[1
]}

Lam, Carolyn S. P. ^{[9
]}

机构：

[1] Duke Univ, Med Ctr, Dept Med, Div Cardiol, Durham, NC 27705 USA

[2] Univ Paris Diderot, Sorbonne Paris Cite, Dept Anesthesia & Crit Care, Paris, France

[3] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[4] SUNY Stony Brook, Div Cardiol, Stony Brook, NY USA

[5] Bayer Pharma AG, Global Clin Dev, Berlin, Germany

[6] Univ Lorraine, Ctr Investigat Clin, INSERM, Nancy, France

[7] CHU Nancy, Nancy, France

[8] Univ Michigan, Med Ctr, Sch Med, Ann Arbor, MI 48109 USA

[9] Natl Heart Ctr Singapore, Dept Cardiol, Singapore, Singapore

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2015年 / 65卷 / 16期

基金：

美国国家卫生研究院; 英国医学研究理事会;

关键词：

NATRIURETIC PEPTIDE LEVELS; SYSTOLIC FUNCTION; EXERCISE CAPACITY; PHOSPHODIESTERASE-5; INHIBITION; NONCARDIAC COMORBIDITIES; PULMONARY-HYPERTENSION; ATRIAL-FIBRILLATION; EUROPEAN-SOCIETY; PROGNOSTIC VALUE; DOUBLE-BLIND;

D O I：

10.1016/j.jacc.2015.03.043

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Recent clinical trials in patients with heart failure with preserved ejection fraction (HFpEF) have provided important insights into participant selection strategies. Historically, HFpEF trials have included patients with relatively preserved left ventricular ejection fraction ranging from 40% to 55% and a clinical history of heart failure. Contemporary HFpEF trials have also incorporated inclusion criteria such as hospitalization for HFpEF, altered functional capacity, cardiac structural and functional abnormalities, and abnormalities in neurohormonal status (e.g., elevated natriuretic peptide levels). Careful analyses of the effect of these patient selection criteria on outcomes in prior trials provide valuable lessons for future trial design. We review recent and ongoing HFpEF clinical trials from a patient selection perspective and appraise trial patient selection methodologies in relation to outcomes. This review reflects discussions between clinicians, scientists, trialists, regulators, and regulatory representatives at the 10th Global CardioVascular Clinical Trialists Forum in Paris, France, on December 6, 2013. (C) 2015 by the American College of Cardiology Foundation.

引用

页码：1668 / 1682

页数：15

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