Skip to main content

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

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.

Call for proposal

H2020-PHC-2014-2015

See other projects for this call

Sub call

H2020-PHC-2014-two-stage

Coordinator

UNIVERSITE CATHOLIQUE DE LOUVAIN
Net EU contribution
€ 602 418,25
Address
Place De L Universite 1
1348 Louvain La Neuve
Belgium

See on map

Region
Région wallonne Prov. Brabant Wallon Arr. Nivelles
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,01

Participants (19)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CLINIQUE UNIVERSITAIRE SAINT-LUC ASBL
Belgium
Net EU contribution
€ 167 337,05
Address
Avenue Hippocrate 10
1200 Bruxelles

See on map

Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Other
Non-EU contribution
€ 0,00
UNIWERSYTET MEDYCZNY IM PIASTOW SLASKICH WE WROCLAWIU
Poland
Net EU contribution
€ 654 585,00
Non-EU contribution
€ 0,00
Associação para Investigação e Desenvolvimento da Faculdade de Medicina
Portugal
Net EU contribution
€ 159 879,66
Address
Av. Prof. Egas Moniz
1649-028 Lisbon

See on map

Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

SPRM - SOCIEDADE PORTUGUESA DE RESSONANCIA MAGNETICA SA
Portugal
Net EU contribution
€ 24 750,00
Address
Rua Duarte Galvao 54
1500 255 Lisboa

See on map

Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

CENTRO HOSPITALAR LISBOA NORTE EPE
Portugal
Net EU contribution
€ 36 875,00
Address
Av Professor Egas Moniz
1649 035 Lisboa

See on map

Region
Continente Área Metropolitana de Lisboa Área Metropolitana de Lisboa
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Net EU contribution
€ 384 404,25
Address
Wellington Square University Offices
OX1 2JD Oxford

See on map

Region
South East (England) Berkshire, Buckinghamshire and Oxfordshire Oxfordshire
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTES
France
Net EU contribution
€ 250 562,50
Address
Allee De L'ile Gloriette 5
44093 Nantes

See on map

Region
Pays de la Loire Pays de la Loire Loire-Atlantique
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTS
Germany
Net EU contribution
€ 471 420,00
Address
Robert-koch-strasse 40
37075 Goettingen

See on map

Region
Niedersachsen Braunschweig Göttingen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
Net EU contribution
€ 591 823,64
Address
Chariteplatz 1
10117 Berlin

See on map

Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
AZIENDA OSPEDALIERA PAPA GIOVANNI XXIII
Italy
Net EU contribution
€ 332 991,86
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

FONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DE BERGAMO
Italy
Net EU contribution
€ 46 590,91
Address
Largo Barozzi 1
24128 Bergamo

See on map

Region
Nord-Ovest Lombardia Bergamo
Activity type
Research Organisations
Non-EU contribution
€ 0,00
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
Greece
Net EU contribution
€ 119 432,80
Address
6 Christou Lada Str
10561 Athina

See on map

Region
Κεντρικός Τομέας Αθηνών Aττική Αττική
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

PANEPISTIMIAKO GENIKO NOSOKOMEIO ATTIKON
Greece
Net EU contribution
€ 7 839,93
Address
Odos Rimini 1
12462 Athina Chaidari

See on map

Region
Δυτικός Τομέας Αθηνών Aττική Αττική
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
UNIVERSITAET LEIPZIG
Germany
Net EU contribution
€ 1 049 677,87
Address
Ritterstrasse 26
04109 Leipzig

See on map

Region
Sachsen Leipzig Leipzig
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

UNIVERSITATKLINIKUM LEIPZIG
Germany
Net EU contribution
€ 35 153,75
Address
Liebigstrasse 27
04103 Leipzig

See on map

Region
Sachsen Leipzig Leipzig
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
France
Net EU contribution
€ 337 095,50
Address
5 Rue Watt
75013 Paris

See on map

Region
Ile-de-France Ile-de-France Paris
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIEN
Germany
Net EU contribution
€ 5 934,13
Address
Alt-moabit 96 A
10559 Berlin

See on map

Region
Berlin Berlin Berlin
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

KLINIKUM DER UNIVERSITAET ZU KOELN
Germany
Net EU contribution
€ 4 115,88
Address
Kerpener Strasse 62
50937 Koeln

See on map

Region
Nordrhein-Westfalen Köln Köln, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
SOCIETE EUROPEENNE DE CARDIOLOGIE
France
Net EU contribution
€ 142 225,00
Address
Route Des Colles 2035
06903 Biot Sophia Antipolis

See on map

Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Alpes-Maritimes
Activity type
Other
Non-EU contribution
€ 0,00