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Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

SD. Solomon, AR. Rizkala, MP. Lefkowitz, VC. Shi, J. Gong, N. Anavekar, SD. Anker, JL. Arango, JL. Arenas, D. Atar, T. Ben-Gal, SA. Boytsov, CH. Chen, VK. Chopra, J. Cleland, J. Comin-Colet, HD. Duengen, LE. Echeverría Correa, G. Filippatos, AJ....

. 2018 ; 11 (7) : e004962. [pub] -

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc19035141

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.

1st Department of Internal Medicine Nara Medical University Kashihara Japan

1st Faculty of Medicine Charles University Prague Czech Republic

Associazione Nazionale Medici Cardiologi Ospedalieri Florence Italy

Attikon University Hospital National and Kapodistrian University of Athens Greece School of Medicine University of Cyprus Greece

Baylor Heart and Vascular Institute Baylor University Medical Center Dallas TX

British Heart Foundation Cardiovascular Research Centre

Cardiology Division Cardiovascular Department Hospital Papa Giovanni XXIII Bergamo Italy

Cardiovascular Division Brigham and Women's Hospital Harvard Medical School Boston MA

Centro de Atención e Investigación Cardiovascular del Potosi SC and Hospital Ángeles San Luis México

Clinic of Cardiology National Cardiology Hospital Sofia Bulgaria

Community Heart Failure Program Department of Cardiology Bellvitge University Hospital and Institut d'Investigació Biomèdica de Bellvitge University of Barcelona Spain

Department of Cardiology B Oslo University Hospital University of Oslo Norway

Department of Cardiology City Hospital Durban South Africa

Department of Cardiology Faculty of Medicine Cumhuriyet University Sivas Turkey

Department of Cardiology Heart Centre Rigshospitalet Copenhagen University Hospital Copenhagen Denmark

Department of Cardiology Hospital Group Twente Almelo and Hengelo The Netherlands

Department of Cardiology Medical University Graz Austria

Department of Cardiology National Heart Centre Singapore

Department of Cardiology Rangueil University Hospital Toulouse France

Department of Cardiology Tampere University Hospital Finland

Department of Cardiology Tongji Hospital Tongji University School of Medicine Shanghai China

Department of Cardiology University Heart Center Zurich University Hospital Zurich Switzerland

Department of Cardiology University Hospitals Leuven Belgium

Department of Cardiology University of Belgrade School of Medicine Belgrade University Medical Center Serbia

Department of Cardiovascular Diseases University Hospital Center Zagreb Croatia

Department of Cardiovascular Medicine Mayo Clinic Rochester MN

Department of Heart Failure Transplantation National Cardiovascular Institute Bratislava Slovakia

Department of Internal Medicine Cardiology Charité Universitaetsmedizin Berlin Campus Virchow Klinikum Berlin Germany

Department of Medicine Karolinska Institutet and Heart and Vascular Theme Karolinska University Hospital Stockholm Sweden

Department of Medicine National Yang Ming University Taipei Taiwan Republic of China

Department of Medicine VA Medical Center and University of Minnesota Minneapolis

Department of Noninvasive Cardiology Medical University of Lodz Poland

Disciplina de Cardiologia Faculdade de Medicina Pontifícia Universidade Católica de Campinas Sao Paulo Brazil

Division of Cardiology and Metabolism Department of Cardiology

Division of Cardiology Department of Medicine Northwestern University Feinberg School of Medicine Chicago IL

Faculty of Medicine Dentistry and Health Sciences University of Melbourne Australia

Guatemalan Heart Institute

Heart and Vascular Center Semmelweis University Budapest Hungary

Heart Failure Unit Cardiology Department Rabin Medical Center Petah Tikva Israel

Heart Failure Unit Medanta Medicity Gurugram Haryana India

Inserm CIC 1433 and Université de Lorraine Centre Hospitalier Ré gional Universitaire Nancy France

Institut de Cardiologie de Montréal Université de Montréal Québec Canada

Instituto FLENI Buenos Aires Argentina

Medical University of South Carolina and Ralph H Johnson Veterans Administration Medical Center Charleston

National Heart Centre Singapore and Duke National University of Singapore

National Research Center for Cardiology of the Ministry of Health of the Russian Federation Moscow Russia

Novartis Pharmaceuticals Corporation East Hanover NJ

Robertson Centre for Biostatistics and Clinical Trials Institute of Health and Wellbeing University of Glasgow United Kingdom National Heart and Lung Institute Royal Brompton and Harefield Hospitals Imperial College London United Kingdom Community Heart Failure Program Department of Cardiology Bellvitge University Hospital and Institut d'Investigació Biomèdica de Bellvitge University of Barcelona Spain

Sarver Heart Center University of Arizona College of Medicine Tucson

Seoul National University Hospital Seoul National University College of Medicine Korea

Shanghai Institute of Cardiovascular Diseases Zhongshan Hospital Fudan University China

St Luke's Heart Institute St Luke's Medical Center Taguig Philippines

Universidad Nacional Mayor de San Marcos Lima Perú Scientia Clinical and Epidemiological Research Institute Trujillo Perú

Universidad Nacional of Cordoba Argentina

University Medical Center Groningen University of Groningen The Netherlands

University Medical Centre Ljubljana Slovenia

University of Medicine and Pharmacy Carol Davila University and Emergency Hospital of Bucharest Romania

Citace poskytuje Crossref.org

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$a Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial / $c SD. Solomon, AR. Rizkala, MP. Lefkowitz, VC. Shi, J. Gong, N. Anavekar, SD. Anker, JL. Arango, JL. Arenas, D. Atar, T. Ben-Gal, SA. Boytsov, CH. Chen, VK. Chopra, J. Cleland, J. Comin-Colet, HD. Duengen, LE. Echeverría Correa, G. Filippatos, AJ. Flammer, M. Galinier, A. Godoy, E. Goncalvesova, S. Janssens, T. Katova, L. Køber, M. Lelonek, G. Linssen, LH. Lund, E. O'Meara, B. Merkely, D. Milicic, BH. Oh, SV. Perrone, N. Ranjith, Y. Saito, JF. Saraiva, S. Shah, PM. Seferovic, M. Senni, AS. Sibulo, D. Sim, NK. Sweitzer, J. Taurio, D. Vinereanu, B. Vrtovec, J. Widimský, MB. Yilmaz, J. Zhou, R. Zweiker, IS. Anand, J. Ge, CSP. Lam, AP. Maggioni, F. Martinez, M. Packer, MA. Pfeffer, B. Pieske, MM. Redfield, JL. Rouleau, DJ. Van Veldhuisen, F. Zannad, MR. Zile, JJV. McMurray,
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$a 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.
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