BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) is a global public health problem with important regional differences. We investigated these differences in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF), the largest and most inclusive global HFpEF trial. METHODS: We studied differences in clinical characteristics, outcomes, and treatment effects of sacubitril/valsartan in 4796 patients with HFpEF from the PARAGON-HF trial, grouped according to geographic region. RESULTS: Regional differences in patient characteristics and comorbidities were observed: patients from Western Europe were oldest (mean 75±7 years) with the highest prevalence of atrial fibrillation/flutter (36%); Central/Eastern European patients were youngest (mean 71±8 years) with the highest prevalence of coronary artery disease (50%); North American patients had the highest prevalence of obesity (65%) and diabetes (49%); Latin American patients were younger (73±9 years) and had a high prevalence of obesity (53%); and Asia-Pacific patients had a high prevalence of diabetes (44%), despite a low prevalence of obesity (26%). Rates of the primary composite end point of total hospitalizations for HF and death from cardiovascular causes were lower in patients from Central Europe (9 per 100 patient-years) and highest in patients from North America (28 per 100 patient-years), which was primarily driven by a greater number of total hospitalizations for HF. The effect of treatment with sacubitril-valsartan was not modified by region (interaction P>0.05). CONCLUSIONS: Among patients with HFpEF recruited worldwide in PARAGON-HF, there were important regional differences in clinical characteristics and outcomes, which may have implications for the design of future clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01920711.

1st Faculty of Medicine Charles University Prague Czech Republic

Associazione Nazionale Medici Cardiologi Ospedalieri Florence Italy

Baylor Heart and Vascular Institute Baylor University Medical Center Dallas TX

British Heart Foundation Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom

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

Department of Cardiology Heart Centre Rigshospitalet Copenhagen University Hospital Denmark

Department of Cardiology University Medical Centre Groningen University of Groningen the Netherlands

Department of Cardiovascular Medicine Mayo Clinic Rochester MN

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

Department of Medicine VA Medical Center and University of Minnesota Minneapolis

Duke NUS Medical School Singapore

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

Heart Failure and Research Max Super Specialty Hospital Saket New Delhi India

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

Institut de Cardiologie de Montréal Université de Montréal QC Canada

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

National Heart Centre Singapore

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

Novartis Pharmaceuticals Corporation East Hanover NJ

Saw Swee Hock School of Public Health National University of Singapore Singapore

Shanghai Institute of Cardiovascular Diseases Zhongshan Hospital Fudan University China

Universidad Nacional of Cordoba Argentina

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ClinicalTrials.gov
NCT01920711