Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure
NCT ID: NCT02599480
Last Updated: 2025-02-10
Study Results
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Basic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2016-09-12
2022-02-16
Brief Summary
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Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.
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Detailed Description
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A major contributor to HFpEF is myocardial remodelling, e.g. hypertrophy and fibrosis, as well as cellular functional/structural modifications leading to alteration in contractile properties and ventricular distensibility. Unfortunately, there are currently no evidence-based treatment strategies.
Study claim The proposed clinical trial will provide a proof of concept in humans for the clinical efficacy of a novel therapeutic concept: β3AR activation to attenuate/prevent cardiac remodeling. Recently, a new, specific agonist at human β3-AR (mirabegron) with higher benefit/risk balance was developed and marketed for clinical use in a non-cardiovascular disease (overactive bladder disease). The trial will test the drug repurposing of mirabegron for the prevention of cardiac remodeling leading to HFpEF.
Using pre-clinical models, the investigators demonstrated that activation of β3AR attenuates myocardial hypertrophy and fibrosis in response to neurohormonal or hemodynamic stresses, without compromising LV function. Therefore, the recent availability of this new drug offers the possibility to test the potential benefit of mirabegron (vs placebo) as add-on therapy (on top of standard care) to prevent/delay myocardial remodelling in patients at high risk of developing HFpEF.
Who can participate? Patients with structural cardiac disease with or without HF symptoms (max. NYHA 2).
What does the study involve? Patients will be requested to go 5 times to the hospital to perform cardiac MRI (3X), echocardiography (3X), exercise tolerance test (2X), Pet scanning (2X) and blood sampling (4X).
Who is the sponsor? The Université catholique de Louvain (UCL) is the academic sponsor and Prof. Jean-Luc Balligand is the principal coordinator of the study.
Who is funding the study? Beta3\_LVH is an investigator-initiated project funded by a Horizon 2020 grant from the European Commission.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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mirabegron
Patients will be orally administererd with 50 mg of mirabegron once a day during 12 months.
mirabegron
50 mg daily during 12 months
Echocardiography
Echocardiography
Cardiac MRI
Cardiac MRI
Maximal exercise capacity
Maximal exercise capacity
Blood sampling
Blood sampling for study assessments and future exploratory studies.
Endothelial function measurement
EndoPAT assessment
18FDG-PET
PET scanning for beige/brown fat activation
Placebo
Patients will be orally administererd with a placebo once a day during 12 months.
Echocardiography
Echocardiography
Cardiac MRI
Cardiac MRI
Maximal exercise capacity
Maximal exercise capacity
Blood sampling
Blood sampling for study assessments and future exploratory studies.
Endothelial function measurement
EndoPAT assessment
18FDG-PET
PET scanning for beige/brown fat activation
Interventions
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mirabegron
50 mg daily during 12 months
Echocardiography
Echocardiography
Cardiac MRI
Cardiac MRI
Maximal exercise capacity
Maximal exercise capacity
Blood sampling
Blood sampling for study assessments and future exploratory studies.
Endothelial function measurement
EndoPAT assessment
18FDG-PET
PET scanning for beige/brown fat activation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Arterial hypertension on stable therapy according to current guideline algorithms (including stable medication for at least four weeks before inclusion),
* Morphological signs of structural cardiac remodelling by echocardiography, i.e. increased LV mass index (110 g/m2 or higher for female; 134 g/m2 or higher for male subjects (Devereux, Reichek 1977)) or end-diastolic wall thickness \> or equal to 13 mm in at least one wall segment
* Patients may have atrial fibrillation (AF), but with well-regulated ventricular response, i.e. heart rate\<100/min (RACE II - (Groenveld et al. 2013, 2013)),
* Written informed consent
* For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject.
Exclusion Criteria
* Documented ischemic cardiac disease
* History of hospitalization for overt heart failure within last 12 months
* Patients after heart transplantation
* Genetic hypertrophic or dilated cardiomyopathy
* Dysthyroidism.
* Severe valvulopathy
* NYHA-class \> II
* BMI \>40 kg/m2
* EF \< 50%, regardless of symptoms
* Known other cause (i.e. COPD) of respiratory dysfunction; patients under positive pressure (CPAP) treatment for sleep apnea syndrome may be included, provided they have been under regular treatment for at least one year before inclusion in the study
* eGFR \< 30 ml/min (by MDRD formula)
* Abnormal liver function tests
* Type I diabetes, complicated type II diabetes
* Patients with anemia
* Patients with bladder outlet obstruction
* Patients using antimuscarinic cholinergic drugs for treatment of OAB
* Current use of digitalis, bupranolol, propranolol, nebivolol
* Patients continuously treated with Sildenafil or other PDE5 inhibitors.
* Current use of antifungal azole derivatives (fluconazole, itraconazole, miconazole, posaconazole, voriconazole)
* Current treatment with mirabegron or indication for future treatment with mirabegron due to other indications
* Contraindication for MRI
* Pregnant or nursing women
* Participation in any other interventional trial
* Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (hormonal implant, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial (participants using a hormone-based method have to be informed of possible effects from the trial medication on contraception)
* Contraindication to mirabegron (e.g. hypersensitivity) or any other components of the trial medication
18 Years
90 Years
ALL
No
Sponsors
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Zentrum für Klinische Studien Leipzig
OTHER
European Clinical Research Infrastructure Network
OTHER
European Society of Cardiology
NETWORK
European Commission
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Northern Lisbon Hospital Center
OTHER
University of Athens
OTHER
Center for Cardiovascular Research Berlin
OTHER
Wroclaw Medical University
OTHER
Papa Giovanni XXIII Hospital
OTHER
Nantes University Hospital
OTHER
University Medical Center Goettingen
OTHER
University of Oxford
OTHER
Jean-Luc Balligand
OTHER
Responsible Party
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Jean-Luc Balligand
Professor
Principal Investigators
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Jean-Luc Balligand, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Université Catholique de Louvain
Locations
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Cliniques universitaires Saint-Luc
Brussels, , Belgium
Nantes university hospital (CHU Nantes)
Nantes, , France
Center for Cardiovascular Research Berlin (CCR/Charité)
Berlin, , Germany
University Medical Center Göttingen (UMG-GOE)
Göttingen, , Germany
University of Leipzig
Leipzig, , Germany
Athens University Medical School (NKUA)
Athens, , Greece
Hospital "Papa Giovanni XXIII" (HPG23)
Bergamo, , Italy
Department of Heart Diseases at Wroclaw Medical University (UMW)
Wroclaw, , Poland
Association for Research and Development of the Faculty of Medicine (AIDFM)
Lisbon, , Portugal
University of Oxford - Division of Cardiovascular Medicine (UOXF)
Oxford, , United Kingdom
Countries
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References
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Belge C, Hammond J, Dubois-Deruy E, Manoury B, Hamelet J, Beauloye C, Markl A, Pouleur AC, Bertrand L, Esfahani H, Jnaoui K, Gotz KR, Nikolaev VO, Vanderper A, Herijgers P, Lobysheva I, Iaccarino G, Hilfiker-Kleiner D, Tavernier G, Langin D, Dessy C, Balligand JL. Enhanced expression of beta3-adrenoceptors in cardiac myocytes attenuates neurohormone-induced hypertrophic remodeling through nitric oxide synthase. Circulation. 2014 Jan 28;129(4):451-62. doi: 10.1161/CIRCULATIONAHA.113.004940. Epub 2013 Nov 4.
Balligand JL. beta(3)-Adrenoceptor stimulation on top of beta(1)-adrenoceptor blockade "Stop or Encore?". J Am Coll Cardiol. 2009 Apr 28;53(17):1539-42. doi: 10.1016/j.jacc.2009.01.048. No abstract available.
Dessy C, Balligand JL. Beta3-adrenergic receptors in cardiac and vascular tissues emerging concepts and therapeutic perspectives. Adv Pharmacol. 2010;59:135-63. doi: 10.1016/S1054-3589(10)59005-7.
Menghoum N, Badii MC, Leroy M, Parra M, Roy C, Lejeune S, Vancraeynest D, Pasquet A, Brito D, Casadei B, Depoix C, Filippatos G, Gruson D, Edelmann F, Ferreira VM, Lhommel R, Mahmod M, Neubauer S, Persu A, Piechnik S, Hellenkamp K, Ikonomidis I, Krakowiak B, Pieske B, Pieske-Kraigher E, Pinto F, Ponikowski P, Senni M, Trochu JN, Van Overstraeten N, Wachter R, Gerber BL, Balligand JL, Beauloye C, Pouleur AC. Exploring the impact of metabolic comorbidities on epicardial adipose tissue in heart failure with preserved ejection fraction. Cardiovasc Diabetol. 2025 Mar 22;24(1):134. doi: 10.1186/s12933-025-02688-7.
Balligand JL, Brito D, Brosteanu O, Casadei B, Depoix C, Edelmann F, Ferreira V, Filippatos G, Gerber B, Gruson D, Hasenclever D, Hellenkamp K, Ikonomidis I, Krakowiak B, Lhommel R, Mahmod M, Neubauer S, Persu A, Piechnik S, Pieske B, Pieske-Kraigher E, Pinto F, Ponikowski P, Senni M, Trochu JN, Van Overstraeten N, Wachter R, Pouleur AC. Repurposing the beta3-Adrenergic Receptor Agonist Mirabegron in Patients With Structural Cardiac Disease: The Beta3-LVH Phase 2b Randomized Clinical Trial. JAMA Cardiol. 2023 Nov 1;8(11):1031-1040. doi: 10.1001/jamacardio.2023.3003.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Planned analyses
Document Type: Statistical Analysis Plan: Trial results according to ICH E3
Other Identifiers
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Beta3_LVH V1.0
Identifier Type: -
Identifier Source: org_study_id
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