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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. €

0

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.

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

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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