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BETA3_LVH SIGNED

A multi-center randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on left ventricular mass and diastolic function in patients with structural heart disease

Total Cost €

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EC-Contrib. €

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Partnership

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 BETA3_LVH project word cloud

Explore the words cloud of the BETA3_LVH project. It provides you a very rough idea of what is the project "BETA3_LVH" about.

repurposing    vascular    mirabegron    additional    risk    overactive    cardiac    hypertension    vo2    adrenergic    doppler    treatment    metabolism    reflecting    measured    clinical    validate    beneficial    function    women    neurohormonal    point    exercise    fat    myocardium    coupling    remodeling    versus    12    heart    trial    effect    indication    prevalent    primary    quantitative    demonstrated    echocardiography    preserved    expression    drug    tolerance    overt    hfpef    myocardial    receptors    diastolic    beta3    centric    discoveries    health    combines    stage    human    structural    classification    mostly    cardiovascular    ejection    peak    hemodynamic    elderly    conceptual    vasculature    months    circulating    hypertrophy    population    prospective    stress    attenuates    obesity    randomized    disease    standard    models    bladder    b3ar    fraction    placebo    beige    remodelling    agonist    co    mri    aha    ventricular    original    biomarkers    brown    fibrosis    decreases    patients    activation    receptor    context   

Project "BETA3_LVH" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITE CATHOLIQUE DE LOUVAIN 

Organization address
address: PLACE DE L UNIVERSITE 1
city: LOUVAIN LA NEUVE
postcode: 1348
website: www.uclouvain.be

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Belgium [BE]
 Project website http://www.beta3lvh.eu/
 Total cost 5˙425˙112 €
 EC max contribution 5˙425˙112 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2014-two-stage
 Funding Scheme RIA
 Starting year 2015
 Duration (year-month-day) from 2015-05-01   to  2020-04-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITE CATHOLIQUE DE LOUVAIN BE (LOUVAIN LA NEUVE) coordinator 819˙545.00
2    UNIVERSITAET LEIPZIG DE (LEIPZIG) participant 1˙082˙718.00
3    THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD UK (OXFORD) participant 607˙468.00
4    UNIWERSYTET MEDYCZNY IM PIASTOW SLASKICH WE WROCLAWIU PL (WROCLAW) participant 480˙615.00
5    CHARITE - UNIVERSITAETSMEDIZIN BERLIN DE (BERLIN) participant 426˙410.00
6    UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS DE (GOETTINGEN) participant 332˙125.00
7    ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK FR (PARIS) participant 306˙625.00
8    ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON EL (ATHINA) participant 300˙000.00
9    AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII IT (BERGAMO) participant 298˙243.00
10    Associação para Investigação e Desenvolvimento da Faculdade de Medicina PT (Lisbon) participant 279˙823.00
11    CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES FR (NANTES) participant 250˙562.00
12    SOCIETE EUROPEENNE DE CARDIOLOGIE FR (BIOT SOPHIA ANTIPOLIS) participant 240˙975.00

Map

 Project objective

Patients with cardiovascular risk factors, e.g. hypertension and obesity are at risk of developing heart failure with preserved ejection fraction (HFpEF), a highly prevalent disease in the elderly, mostly women population. There is currently no specific, defined treatment for HFpEF, beyond control of risk factors. Activation of cardiac and vascular Beta3-adrenergic receptors (B3AR) represents a new concept and a novel target for structural cardiac disease. B3AR expression and coupling were demonstrated in human myocardium and vasculature. In pre-clinical models with expression of the human receptor, its activation attenuates myocardial remodelling, i.e. decreases hypertrophy and fibrosis in response to neurohormonal or hemodynamic stress. Mirabegron is a new agonist of B3AR available for human use, that was recently introduced for a non-cardiovascular indication (overactive bladder disease). The primary objective of the project is to design and implement a multi-centric, prospective, randomized, placebo-controlled clinical trial testing the additional beneficial effect of mirabegron, versus placebo over 12 months on top of standard treatment of patients carrying structural cardiac disease without overt heart failure (stage B of AHA classification); the co-primary end-point will be the quantitative change in myocardial hypertrophy measured by cardiac MRI; and in diastolic ventricular function, measured by Doppler echocardiography (E/E’); in addition, exercise tolerance (peak VO2) will be measured as well as circulating biomarkers reflecting both myocardial remodeling and function. In addition, we will test the effect of mirabegron on beige/brown fat activation and metabolism. Our proposal therefore combines a major conceptual advance and repurposing of an original drug to validate pre-clinical discoveries in the context of a major health problem.

 Deliverables

List of deliverables.
Publication of trial rationale/design Documents, reports 2020-04-01 17:23:22
Abstracts presentation at heart failure meetings Documents, reports 2020-04-01 17:23:22
Functional website Demonstrators, pilots, prototypes 2020-04-01 17:23:22

Take a look to the deliverables list in detail:  detailed list of BETA3_LVH deliverables.

 Publications

year authors and title journal last update
List of publications.
2016 ESC
On-going EU Projects
published pages: , ISSN: , DOI:
2020-04-01
2018 Anne-Catherine Pouleur, Stefan Anker, Dulce Brito, Oana Brosteanu, Dirk Hasenclever, Barbara Casadei, Frank Edelmann, Gerasimos Filippatos, Damien Gruson, Ignatios Ikonomidis, Renaud Lhommel, Masliza Mahmod, Stefan Neubauer, Alexandre Persu, Bernhard L. Gerber, Stefan Piechnik, Burkert Pieske, Elisabeth Pieske-Kraigher, Fausto Pinto, Piotr Ponikowski, Michele Senni, Jean-Noël Trochu, Nancy Van Overstraeten, Rolf Wachter, Jean-Luc Balligand
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 (Be
published pages: , ISSN: 2055-5822, DOI: 10.1002/ehf2.12306
ESC Heart Failure 2020-04-01
2016 Lauriane Y. M. Michel, Jean-Luc Balligand
New and Emerging Therapies and Targets: Beta-3 Agonists
published pages: 205-223, ISSN: , DOI: 10.1007/164_2016_88
2020-04-01
2018 S. Piechnik
Piechnik Group: Myocardial functional T1 mapping – Advanced cardiac magnetic resonance imaging techniques
published pages: , ISSN: , DOI:
2020-04-01
2015 Frédéric Soumois
Une molécule pour soulager le coeur
published pages: , ISSN: , DOI:
Le Soir daily 2020-04-01
2015 Jean-Luc Balligand
Vers un nouveau traitement de l\'insuffisance cardiaque ?
published pages: , ISSN: , DOI:
2020-04-01
2015 Nancy Van Overstraeten
Towards a new treatment for cardiac remodeling ?
published pages: , ISSN: , DOI:
2020-04-01
2015 EU
A multi-center randomized, placebo-controlled trial of mirabegron, a new beta3-adrenergic receptor agonist on left ventricular mass and diastolic function in patients with structural heart disease
published pages: , ISSN: , DOI:
2020-04-01
2015 Nancy Van Overstraeten
Youtube video
published pages: , ISSN: , DOI:
2020-04-01
2015 Jean-Luc Balligand
seminar
published pages: , ISSN: , DOI:
2020-04-01
2015 Anne-Catherine Pouleur
Seminar: Leçon publique sur l\'HFpEF
published pages: , ISSN: , DOI:
2020-04-01

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The information about "BETA3_LVH" are provided by the European Opendata Portal: CORDIS opendata.

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