@article{3107226,
    title = "Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial",
    author = "Solomon, S.D. and Rizkala, A.R. and Lefkowitz, M.P. and Shi, V.C. and Gong, J. and Anavekar, N. and Anker, S.D. and Arango, J.L. and Arenas, J.L. and Atar, D. and Ben-Gal, T. and Boytsov, S.A. and Chen, C.-H. and Chopra, V.K. and Cleland, J. and Comin-Colet, J. and Duengen, H.-D. and Echeverría Correa, L.E. and Filippatos, G. and Flammer, A.J. and Galinier, M. and Godoy, A. and Goncalvesova, E. and Janssens, S. and Katova, T. and Køber, L. and Lelonek, M. and Linssen, G. and Lund, L.H. and O'Meara, E. and Merkely, B. and Milicic, D. and Oh, B.-H. and Perrone, S.V. and Ranjith, N. and Saito, Y. and Saraiva, J.F. and Shah, S. and Seferovic, P.M. and Senni, M. and Sibulo, A.S. and Sim, D. and Sweitzer, N.K. and Taurio, J. and Vinereanu, D. and Vrtovec, B. and Widimský, J. and Yilmaz, M.B. and Zhou, J. and Zweiker, R. and Anand, I.S. and Ge, J. and Lam, C.S.P. and Maggioni, A.P. and Martinez, F. and Packer, M. and Pfeffer, M.A. and Pieske, B. and Redfield, M.M. and Rouleau, J.L. and Van Veldhuisen, D.J. and Zannad, F. and Zile, M.R. and McMurray, J.J.V.",
    journal = "Circulation: Heart Failure",
    year = "2018",
    volume = "11",
    number = "7",
    publisher = "Lippincott Williams and Wilkins",
    issn = "1941-3289",
    doi = "10.1161/CIRCHEARTFAILURE.118.004962",
    keywords = "amino terminal pro brain natriuretic peptide;  angiotensin receptor;  angiotensin receptor antagonist;  calcium channel blocking agent;  dipeptidyl carboxypeptidase inhibitor;  enkephalinase inhibitor;  mineralocorticoid antagonist;  sacubitril plus valsartan;  valsartan;  angiotensin 1 receptor antagonist;  angiotensin receptor antagonist;  beta adrenergic receptor blocking agent;  dipeptidyl carboxypeptidase inhibitor;  mineralocorticoid antagonist;  valsartan, Article;  atrial fibrillation;  chronic kidney failure;  clinical trial (topic);  diabetes mellitus;  double blind procedure;  drug efficacy;  drug safety;  dyspnea;  edema;  female;  glomerulus filtration rate;  heart disease;  heart failure;  heart failure with preserved ejection fraction;  heart left ventricle ejection fraction;  hospitalization;  human;  major clinical study;  mortality;  priority journal;  aged;  controlled study;  drug effect;  heart failure;  heart left ventricle function;  heart stroke volume;  male;  middle aged;  pathophysiology;  randomized controlled trial;  very elderly, Adrenergic beta-Antagonists;  Aged;  Aged, 80 and over;  Angiotensin II Type 1 Receptor Blockers;  Angiotensin Receptor Antagonists;  Angiotensin-Converting Enzyme Inhibitors;  Clinical Trials as Topic;  Female;  Heart Failure;  Humans;  Male;  Middle Aged;  Mineralocorticoid Receptor Antagonists;  Stroke Volume;  Valsartan;  Ventricular Function, Left",
    abstract = "Background: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality. Methods and Results: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease. Conclusions: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711. © 2018 American Heart Association, Inc."
}