Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials

Yancy, 2005, Heart failure in African Americans., Am J Cardiol, 96, 3i, 10.1016/j.amjcard.2005.07.028

Redfield, 2002, Plasma brain natriuretic peptide concentration: impact of age and gender., J Am Coll Cardiol, 40, 976, 10.1016/S0735-1097(02)02059-4

Bajaj, 2018, Racial differences in plasma levels of N-terminal pro-B-type natriuretic peptide and outcomes: the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study., JAMA Cardiol, 3, 11, 10.1001/jamacardio.2017.4207

McNamara, 2014, G-protein beta-3 subunit genotype predicts enhanced benefit of fixed-dose isosorbide dinitrate and hydralazine: results of A-HeFT., JACC Heart Fail, 2, 551, 10.1016/j.jchf.2014.04.016

Vaduganathan, 2016, Transforming drug development in heart failure: navigating the regulatory crossroads., Circ Heart Fail, 9, 9, 10.1161/CIRCHEARTFAILURE.116.003192

Smith, 2012, Impact of ancestry and common genetic variants on QT interval in African Americans., Circ Cardiovasc Genet, 5, 647, 10.1161/CIRCGENETICS.112.962787

Heiat, 2002, Representation of the elderly, women, and minorities in heart failure clinical trials., Arch Intern Med, 162, 1682, 10.1001/archinte.162.15.1682

Fonarow, 2007, Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry., J Am Coll Cardiol, 50, 768, 10.1016/j.jacc.2007.04.064

Steinberg, 2012, Trends in patients hospitalized with heart failure and preserved left ventricular ejection fraction: prevalence, therapies, and outcomes., Circulation, 126, 65, 10.1161/CIRCULATIONAHA.111.080770

Yancy, 2006, Clinical presentation, management, and in-hospital outcomes of patients admitted with acute decompensated heart failure with preserved systolic function: a report from the Acute Decompensated Heart Failure National Registry (ADHERE) Database., J Am Coll Cardiol, 47, 76, 10.1016/j.jacc.2005.09.022

Fonarow, 2010, Improving evidence-based care for heart failure in outpatient cardiology practices: primary results of the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF)., Circulation, 122, 585, 10.1161/CIRCULATIONAHA.109.934471

Khariton, 2018, Health status variation across practices in outpatients with heart failure: insights from the CHAMP-HF (Change the Management of Patients With Heart Failure) Registry., Circ Cardiovasc Qual Outcomes, 11, e004668, 10.1161/CIRCOUTCOMES.118.004668

Gerber, 2015, A contemporary appraisal of the heart failure epidemic in Olmsted County, Minnesota, 2000 to 2010., JAMA Intern Med, 175, 996, 10.1001/jamainternmed.2015.0924

Gottdiener, 2002, Outcome of congestive heart failure in elderly persons: influence of left ventricular systolic function: the Cardiovascular Health Study., Ann Intern Med, 137, 631, 10.7326/0003-4819-137-8-200210150-00006

Lee, 2009, Relation of disease pathogenesis and risk factors to heart failure with preserved or reduced ejection fraction: insights from the framingham heart study of the national heart, lung, and blood institute., Circulation, 119, 3070, 10.1161/CIRCULATIONAHA.108.815944

Silverman, 2016, Impact of race, ethnicity, and multimodality biomarkers on the incidence of new-onset heart failure with preserved ejection fraction (from the Multi-Ethnic Study of Atherosclerosis)., Am J Cardiol, 117, 1474, 10.1016/j.amjcard.2016.02.017

Adams, 2005, Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE)., Am Heart J, 149, 209, 10.1016/j.ahj.2004.08.005

Patel, 2017, Assessing the eligibility criteria in phase iii randomized controlled trials of drug therapy in heart failure with preserved ejection fraction: the critical play-off between a “pure” patient phenotype and the generalizability of trial findings., J Card Fail, 23, 517, 10.1016/j.cardfail.2017.04.006

Sullivan, 2018, Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction., Am Heart J, 197, 43, 10.1016/j.ahj.2017.10.025

Vitale, 2017, Under-representation of elderly and women in clinical trials., Int J Cardiol, 232, 216, 10.1016/j.ijcard.2017.01.018

Franceschini, 2013, Genome-wide association analysis of blood-pressure traits in African-ancestry individuals reveals common associated genes in African and non-African populations., Am J Hum Genet, 93, 545, 10.1016/j.ajhg.2013.07.010

Thomas, 2011, Association of race/ethnicity with clinical risk factors, quality of care, and acute outcomes in patients hospitalized with heart failure., Am Heart J, 161, 746, 10.1016/j.ahj.2011.01.012

Melloni, 2010, Representation of women in randomized clinical trials of cardiovascular disease prevention., Circ Cardiovasc Qual Outcomes, 3, 135, 10.1161/CIRCOUTCOMES.110.868307

Harris, 2000, Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute., N Engl J Med, 343, 475, 10.1056/NEJM200008173430706

Zhang, 2013, Reporting and representation of ethnic minorities in cardiovascular trials: a systematic review., Am Heart J, 166, 52, 10.1016/j.ahj.2013.03.022

Vaduganathan, 2018, Globalization of heart failure clinical trials: a systematic review of 305 trials conducted over 16 years., Eur J Heart Fail, 20, 1068, 10.1002/ejhf.2018.20.issue-6

Samman Tahhan, 2018, Evolving landscape of clinical trials in heart failure: patient populations, endpoint selection, and regions of enrollment., Curr Heart Fail Rep, 15, 10, 10.1007/s11897-018-0374-z

Ramsey, 2016, Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial., Clin Trials, 13, 319, 10.1177/1740774516631735

Health NIo. NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Amended October 2001. https://grants.nih.gov/grants/funding/women_min/guidelines.htm. Accessed July 14, 2018.