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Abstract
Aims
Progressive left ventricular (LV) remodelling with cardiac myocyte hypertrophy, myocardial fibrosis, and endothelial dysfunction plays a key role in the onset and progression of heart failure with preserved ejection fraction. The Beta3‐LVH trial will test the hypothesis that the β3 adrenergic receptor agonist mirabegron will improve LV hypertrophy and diastolic function in patients with hypertensive structural heart disease at high risk for developing heart failure with preserved ejection fraction.
Methods and results
Beta3‐LVH is a randomized, placebo‐controlled, double‐blind, two‐armed, multicentre, European, parallel group study. A total of 296 patients will be randomly assigned to receive either mirabegron 50 mg daily or placebo over 12 months. The main inclusion criterion is the presence of LV hypertrophy, that is, increased LV mass index (LVMi) or increased wall thickening by echocardiography. The co‐primary endpoints are a change in LVMi by cardiac magnetic resonance imaging and a change in LV diastolic function (assessed by the E/e′ ratio). Secondary endpoints include mirabegron's effects on cardiac fibrosis, left atrial volume index, maximal exercise capacity, and laboratory markers. Two substudies will evaluate mirabegron's effect on endothelial function by pulse amplitude tonometry and brown fat activity by positron emission tomography using 17F‐fluorodeoxyglucose. Morbidity and mortality as well as safety aspects will also be assessed.
Conclusions
Beta3‐LVH is the first large‐scale clinical trial to evaluate the effects of mirabegron on LVMi and diastolic function in patients with LVH. Beta3‐LVH will provide important information about the clinical course of this condition and may have significant impact on treatment strategies and future trials in these patients.
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Details
1 Cardiovascular Department, Cliniques Universitaires Saint‐Luc, Université catholique de Louvain, Brussels, Belgium
2 Innovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany; Division of Cardiology and Metabolism—Heart Failure, Cachexia and Sarcopenia, Department of Cardiology, Berlin Brandenburg Center for Regenerative Therapies, Charité University of Medicine, Berlin, Germany
3 Department of Cardiology, CHLN, CCUL (Cardiovascular Centre), AIDFM, Hospital de Santa Maria, Universidade de Lisboa, Lisbon, Portugal
4 Clinical Trial Centre Leipzig—ZKS, Faculty of Medicine, Leipzig University, Leipzig, Germany
5 Institute for Medical Informatics, Statistics & Epidemiology—IMISE, Faculty of Medicine, Leipzig University, Leipzig, Germany
6 Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK
7 Department of Internal Medicine and Cardiology, Charité—Universitätsmedizin Berlin—Campus Virchow Klinikum, Berlin, Germany; German Center for Cardiovascular Research (DZHK), Partner Site, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany
8 National and Kapodistrian University of Athens, School of Medicine and Department of Cardiology, Heart Failure Unit, Athens University Hospital Attikon, Athens, Greece
9 Clinical Biology Department, Cliniques Universitaires Saint‐Luc, Université catholique de Louvain, Brussels, Belgium
10 Nuclear Medicine Department, Cliniques Universitaires Saint‐Luc, Université catholique de Louvain, Brussels, Belgium
11 Cardiovascular Imaging Core Laboratory, Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK
12 Department of Internal Medicine and Cardiology, Charité—Universitätsmedizin Berlin—Campus Virchow Klinikum, Berlin, Germany; German Center for Cardiovascular Research (DZHK), Partner Site, Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; Department of Internal Medicine and Cardiology, German Heart Institute, Berlin, Germany
13 Division of Cardiology and Metabolism—Heart Failure, Cachexia and Sarcopenia, Department of Cardiology, Berlin Brandenburg Center for Regenerative Therapies, Charité University of Medicine, Berlin, Germany
14 Department of Heart Diseases, Wrocław Medical University, Wrocław, Poland; Cardiology Department, Military Hospital, Wrocław, Poland
15 Department Cardiovascular Medicine, Cardiology Division, Papa Giovanni XXIII Hospital, Bergamo, Italy
16 Institut du thorax, Centre Hospitalier Universitaire de Nantes, Nantes, France; Medical School, University of Nantes, Nantes, France
17 Clinic for Cardiology and Pneumology, University of Göttingen Medical Centre, Göttingen, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Göttingen, Göttingen, Germany
18 Department of Medicine, Pole of Pharmacology and Therapeutics (FATH), Institut de Recherche Expérimentale et Clinique (IREC), Cliniques Universitaires Saint‐Luc, Université catholique de Louvain, Brussels, Belgium