CORDIS
EU research results

CORDIS

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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

Project information

Grant agreement ID: 634559

Status

Ongoing project

  • Start date

    1 May 2015

  • End date

    30 April 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 425 112,99

  • EU contribution

    € 5 425 112,98

Coordinated by:

UNIVERSITE CATHOLIQUE DE LOUVAIN

Belgium

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.
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Coordinator

UNIVERSITE CATHOLIQUE DE LOUVAIN

Address

Place De L Universite 1
1348 Louvain La Neuve

Belgium

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 819 545,51

Participants (11)

UNIWERSYTET MEDYCZNY IM PIASTOW SLASKICH WE WROCLAWIU

Poland

EU Contribution

€ 480 615

Associação para Investigação e Desenvolvimento da Faculdade de Medicina

Portugal

EU Contribution

€ 279 823,72

THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD

United Kingdom

EU Contribution

€ 607 468,75

CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES

France

EU Contribution

€ 250 562,50

UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS

Germany

EU Contribution

€ 332 125

CHARITE - UNIVERSITAETSMEDIZIN BERLIN

Germany

EU Contribution

€ 426 410

AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII

Italy

EU Contribution

€ 298 243,75

ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON

Greece

EU Contribution

€ 300 000

UNIVERSITAET LEIPZIG

Germany

EU Contribution

€ 1 082 718,75

ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK

France

EU Contribution

€ 306 625

SOCIETE EUROPEENNE DE CARDIOLOGIE

France

EU Contribution

€ 240 975

Project information

Grant agreement ID: 634559

Status

Ongoing project

  • Start date

    1 May 2015

  • End date

    30 April 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 5 425 112,99

  • EU contribution

    € 5 425 112,98

Coordinated by:

UNIVERSITE CATHOLIQUE DE LOUVAIN

Belgium