Evidence map›Paper›PMID 29932311›Full record

ArticleESC heart failure2018

Rationale and design of a multicentre, randomized, placebo-controlled trial of mirabegron, a Beta3-adrenergic receptor agonist on left ventricular mass and diastolic function in patients with structural heart disease Beta3-left ventricular hypertrophy (Beta3-LVH).

Anne-Catherine Pouleur, Stefan Anker, Dulce Brito, Oana Brosteanu, Dirk Hasenclever, Barbara Casadei, Frank Edelmann, Gerasimos Filippatos, Damien Gruson, Ignatios Ikonomidis and 15 more

Erratum issuedOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in ESC heart failure, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
7.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Physiological and metabolic functions of the βJournal of physiology and biochemistry · 2024
    Review
  5. Review
  6. Review
  7. Article
  8. Mirabegron Ameliorated Atherosclerosis of ApoECardiovascular drugs and therapy · 2022
    Article
  9. Review
  10. Review
  11. Article
  12. Targeting Adrenergic Receptors in Metabolic Therapies for Heart Failure.International journal of molecular sciences · 2021
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. βeLife · 2020
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 15 institutions in 10 countries.

Anne-Catherine PouleurCardiovascular Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Stefan AnkerInnovative Clinical Trials, Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany.
Dulce BritoDepartment of Cardiology, CHLN, CCUL (Cardiovascular Centre), AIDFM, Hospital de Santa Maria, Universidade de Lisboa, Lisbon, Portugal.
Oana BrosteanuClinical Trial Centre Leipzig-ZKS, Faculty of Medicine, Leipzig University, Leipzig, Germany.
Dirk HasencleverInstitute for Medical Informatics, Statistics & Epidemiology-IMISE, Faculty of Medicine, Leipzig University, Leipzig, Germany.
Barbara CasadeiDivision of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.
Frank EdelmannDepartment of Internal Medicine and Cardiology, Charité-Universitätsmedizin Berlin-Campus Virchow Klinikum, Berlin, Germany.
Gerasimos FilippatosNational and Kapodistrian University of Athens, School of Medicine and Department of Cardiology, Heart Failure Unit, Athens University Hospital Attikon, Athens, Greece.
Damien GrusonClinical Biology Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Ignatios IkonomidisNational and Kapodistrian University of Athens, School of Medicine and Department of Cardiology, Heart Failure Unit, Athens University Hospital Attikon, Athens, Greece.
Renaud LhommelNuclear Medicine Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Masliza MahmodCardiovascular Imaging Core Laboratory, Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Stefan NeubauerCardiovascular Imaging Core Laboratory, Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Alexandre PersuCardiovascular Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Bernhard L GerberCardiovascular Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Stefan PiechnikCardiovascular Imaging Core Laboratory, Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Division of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.
Burkert PieskeDepartment of Internal Medicine and Cardiology, Charité-Universitätsmedizin Berlin-Campus Virchow Klinikum, Berlin, Germany.
Elisabeth Pieske-KraigherDivision of Cardiovascular Medicine, Radcliffe Department of Medicine, University of Oxford, John Radcliffe Hospital, Oxford, UK.
Fausto PintoDivision of Cardiology and Metabolism-Heart Failure, Cachexia and Sarcopenia, Department of Cardiology, Berlin Brandenburg Center for Regenerative Therapies, Charité University of Medicine, Berlin, Germany.
Piotr PonikowskiDepartment of Heart Diseases, Wrocław Medical University, Wrocław, Poland.
Michele SenniDepartment Cardiovascular Medicine, Cardiology Division, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Jean-Noël TrochuInstitut du thorax, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Nancy Van OverstraetenCardiovascular Department, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Rolf WachterClinic for Cardiology and Pneumology, University of Göttingen Medical Centre, Göttingen, Germany.
Jean-Luc BalligandDepartment of Medicine, Pole of Pharmacology and Therapeutics (FATH), Institut de Recherche Expérimentale et Clinique (IREC), Cliniques Universitaires Saint-Luc, Université catholique de Louvain, B1.53.09, 52 avenue Mounier, 1200, Brussels, Belgium.
Cliniques Universitaires Saint-Luc · BEUniversity of Oxford · GBBerlin Institute of Health at Charité - Universitätsmedizin Berlin · DELeipzig University · DENational and Kapodistrian University of Athens · GRBerlin-Brandenburger Centrum für Regenerative Therapien · DECentre Hospitalier Universitaire de Nantes · FRCharité - Universitätsmedizin Berlin · DEHeart Foundation · USHospital de Santa Maria · PTJohn Radcliffe Hospital · GBOspedale Papa Giovanni XXIII · ITOxford BioMedica (United Kingdom) · GBUCLouvain · BEUniversitätsmedizin Göttingen · DE

Funding

ATHEROGENIC &ANTIATHEROGENIC LIPOPROTEINS IN CADF32HL008004 · NHLBI · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI WILSON, PAUL R · 1989 to 1990
–
PREVENTIVE CARDIOLOGY ACADEMIC AWARDK07HL001115 · NHLBI · SAINT LOUIS UNIVERSITY · PI COHEN, JEROME D · 1985 to 1987
–
British Heart Foundation RE/08/004British Heart Foundation RG/11/15/29375British Heart Foundation RG/16/12/32451
6 · The paper itself

Abstract

aimsProgressive 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 β METHODS AND

resultsBeta3-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.

conclusionsBeta3-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.

Indexed as

AcetanilidesAdolescentAdrenergic beta-3 Receptor AgonistsAdultAgedAged, 80 and overDiastoleDisease ProgressionDouble-Blind MethodEchocardiographyFemaleFollow-Up StudiesHeart VentriclesHumansHypertrophy, Left VentricularMagnetic Resonance Imaging, CineAcetanilidesAdrenergic beta-3 Receptor AgonistsmirabegronThiazolesHeart failure with preserved ejection fractionHypertensive structural heart diseaseMirabegronβ3 adrenergic receptor

Identifiers

PMID29932311
PMCPMC6165933
OpenAlexW2810008907

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.