Hypertrophy, Left VentricularPhase 2Beta3_LVHNCT02599480
Assessment of Efficacy of Mirabegron, a New beta3-adrenergic Receptor in the Prevention of Heart Failure
A Phase 2 study testing mirabegron, Echocardiography and Cardiac MRI in people with Hypertrophy, Left Ventricular, run by Jean-Luc Balligand at 10 sites in 8 countries.
Trial summary
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertrophy, Left Ventricular
- What is being tested?
- mirabegron, Echocardiography and Cardiac MRI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 296 participants
- Where
- 10 sitesin 8 countries
- Study dates
- 12 Sep 2016to 16 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years
- 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.
Who cannot join
- Unstable hypertension with systolic BP≥160 mm Hg and/or diastolic BP≥100 mm Hg (based on office measurement, not ambulatory measurement)
- 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.
Show all 26Show fewer
- 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
Trial locations and contacts
10 sites in 8 countries.
10 sites in 8 countries
Germany3 sites
Center for Cardiovascular Research Berlin (CCR/Charité)
Berlin, 10115
University Medical Center Göttingen (UMG-GOE)
Göttingen, 37099
University of Leipzig
Leipzig
Poland1 site
Department of Heart Diseases at Wroclaw Medical University (UMW)
Wroclaw, 50-981
Portugal1 site
Association for Research and Development of the Faculty of Medicine (AIDFM)
Lisbon, 1649-028
United Kingdom1 site
University of Oxford - Division of Cardiovascular Medicine (UOXF)
Oxford, OX3 9DU
About this study
Official title: A Multi-centre 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
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II).
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.
Read the detailed description
Background Heart failure (HF) represents a major and growing public health burden. Patients with HF are classically divided into two groups: those with HF with preserved ejection fraction (HFpEF), and those with HF and reduced ejection fraction (HFrEF). As HF is a progressive disorder increasing with age, the proportion of these patients is rising due to the aging of the population. Beside costs, HFpEF also puts a heavy burden on the quality of life of (mostly elderly) patients, with a loss of autonomy and the dyscomfort of repeated hospitalisations. Therefore, HFpEF is a chronic, costly, debilitating disease.
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
- Hypertrophy, Left Ventricular
- Being tested
- mirabegron, Echocardiography, Cardiac MRI, Maximal exercise capacity, Blood sampling
- Keywords
- HFpEF, left ventricular hypertrophy, cardiac remodeling,
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called Betmiga, Myrbetriq
50 mg daily during 12 months
EchocardiographyProcedure or surgery
Echocardiography
Cardiac MRIProcedure or surgery
Cardiac MRI
Maximal exercise capacityProcedure or surgery
Maximal exercise capacity
Blood samplingProcedure or surgery
Blood sampling for study assessments and future exploratory studies.
Endothelial function measurementProcedure or surgery
EndoPAT assessment
18FDG-PETRadiation
PET scanning for beige/brown fat activation
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Active comparator | Patients will be orally administererd with 50 mg of mirabegron once a day during 12 months. Receives: Drug: mirabegron; Procedure: Echocardiography; Procedure: Cardiac MRI; Procedure: Maximal exercise capacity; Procedure: Blood sampling; Procedure: Endothelial function measurement; Radiation: 18FDG-PET |
| Placebo | Placebo comparator | Patients will be orally administererd with a placebo once a day during 12 months. Receives: Procedure: Echocardiography; Procedure: Cardiac MRI; Procedure: Maximal exercise capacity; Procedure: Blood sampling; Procedure: Endothelial function measurement; Radiation: 18FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass index (LVMI)
Change in left ventricular mass index (LVMI in g/m2, defined as left ventricular mass divided by body surface) measured at baseline and 12 months after randomisation.
Measured: 12 months
Change in diastolic function
Change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e') measured at baseline and 12 months after randomisation.
Measured: 12 months
Secondary outcomes (8)
Cardiac fibrosis
Cardiac fibrosis at baseline and at 12 months. Fibrosis is a key pathogenic mechanism of diastolic dysfunction, which is at the origin of HFpEF
Measured: 12 months
Left atrial volume index
Left atrial volume index at baseline and at 12 months. This parameter determines diastolic filling (and was shown to predict treatment efficacy in HFpEF in the J-DHF trial (Yamamoto et al. 2013))
Measured: 12 months
LV mass index (by cardiac MRI)
LV mass index (by cardiac MRI) at 6 months,
Measured: 6 months
Diastolic function (E/e')
Diastolic function (E/e') at 6 months
Measured: 6 months
serum biomarkers
serum biomarkers (Galectin3, GDF15, NT-proBNP, hsTnT)
Measured: 3, 6, 12 months
metabolic parameters
metabolic parameters (fasting glucose, modified HOMA test, HbA1c, serum lipids)
Measured: 3, 6, 12 months
Maximal exercise capacity
Maximal exercise capacity (peak VO2) at baseline and 12 months.
Measured: 12 months
Emergence of treatment-related adverse events
Incidence of Treatment-Emergent Adverse Events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study start12 Sep 2016
- Primary completion26 Feb 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hypertrophy, Left VentricularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Luc Balligand
- Sponsor type
- University, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig, European Clinical Research Infrastructure Network, European Society of Cardiology, European Commission, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Northern Lisbon Hospital Center, University of Athens, Center for Cardiovascular Research Berlin, Wroclaw Medical University, Papa Giovanni XXIII Hospital, Nantes University Hospital, University Medical Center Goettingen, University of Oxford
- Responsible party
- Sponsor-investigator, Jean-Luc Balligand, Université Catholique de Louvain
- Investigators
- Jean-Luc Balligand, Prof. MD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599480
- Sponsor's protocol ID
- Beta3_LVH V1.0
- Acronym
- Beta3_LVH
- Status last verified
- Feb 2025
- First submitted
- 30 Oct 2015
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data required to reach aims in an approved proposal, after de-identification, will be made available to investigators whose proposed use of the data has been approved by the study's Executive Committee. Proposals may be submitted up to 36 months after publication of the study results and should be directed to Jean-Luc.Balligand@uclouvain.be.
Publications
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.
PubMed 24190960Balligand 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.
PubMed 19389565Dessy 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.
PubMed 20933201Menghoum 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.
PubMed 40121452Balligand 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.
PubMed 37728907
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre 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
- ClinicalTrials.gov ID
- NCT02599480
- Acronym / sponsor ID
- Beta3_LVH / Beta3_LVH V1.0
- Conditions
- Hypertrophy, Left Ventricular
- Keywords
- HFpEF, left ventricular hypertrophy, cardiac remodeling,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Jean-Luc BalligandUniversity, hospital or other
- Collaborators
- Zentrum für Klinische Studien Leipzig, European Clinical Research Infrastructure Network, European Society of Cardiology, European Commission, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Northern Lisbon Hospital Center, University of Athens, Center for Cardiovascular Research Berlin, Wroclaw Medical University, Papa Giovanni XXIII Hospital, Nantes University Hospital, University Medical Center Goettingen, University of Oxford
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II).
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.
Detailed description
Background Heart failure (HF) represents a major and growing public health burden. Patients with HF are classically divided into two groups: those with HF with preserved ejection fraction (HFpEF), and those with HF and reduced ejection fraction (HFrEF). As HF is a progressive disorder increasing with age, the proportion of these patients is rising due to the aging of the population. Beside costs, HFpEF also puts a heavy burden on the quality of life of (mostly elderly) patients, with a loss of autonomy and the dyscomfort of repeated hospitalisations. Therefore, HFpEF is a chronic, costly, debilitating disease.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mirabegron | Active comparator | Drug: mirabegron, Procedure: Echocardiography, Procedure: Cardiac MRI, Procedure: Maximal exercise capacity, Procedure: Blood sampling, Procedure: Endothelial function measurement, Radiation: 18FDG-PETPatients will be orally administererd with 50 mg of mirabegron once a day during 12 months. |
| Placebo | Placebo comparator | Procedure: Echocardiography, Procedure: Cardiac MRI, Procedure: Maximal exercise capacity, Procedure: Blood sampling, Procedure: Endothelial function measurement, Radiation: 18FDG-PETPatients will be orally administererd with a placebo once a day during 12 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 90 years
- 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
Key exclusion criteria (26 listed)
- Unstable hypertension with systolic BP≥160 mm Hg and/or diastolic BP≥100 mm Hg (based on office measurement, not ambulatory measurement)
- Documented ischemic cardiac disease
- History of hospitalization for overt heart failure within last 12 months
- Patients after heart transplantation
- Genetic hypertrophic or dilated cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegronAlso: Betmiga, Myrbetriq50 mg daily during 12 months | Drug | mirabegron |
| EchocardiographyEchocardiography | Procedure or surgery | Placebo, mirabegron |
| Cardiac MRICardiac MRI | Procedure or surgery | Placebo, mirabegron |
| Maximal exercise capacityMaximal exercise capacity | Procedure or surgery | Placebo, mirabegron |
| Blood samplingBlood sampling for study assessments and future exploratory studies. | Procedure or surgery | Placebo, mirabegron |
| Endothelial function measurementEndoPAT assessment | Procedure or surgery | Placebo, mirabegron |
| 18FDG-PETPET scanning for beige/brown fat activation | Radiation | Placebo, mirabegron |
Primary outcome
Change in left ventricular mass index (LVMI)
Time frame: 12 months
Change in left ventricular mass index (LVMI in g/m2, defined as left ventricular mass divided by body surface) measured at baseline and 12 months after randomisation.
Change in diastolic function
Time frame: 12 months
Change in diastolic function, assessed as the ratio of peak early transmitral ventricular filling velocity to early diastolic tissue Doppler velocity (E/e') measured at baseline and 12 months after randomisation.
8 secondary outcomes
Cardiac fibrosis
Time frame: 12 months
Left atrial volume index
Time frame: 12 months
LV mass index (by cardiac MRI)
Time frame: 6 months
Diastolic function (E/e')
Time frame: 6 months
serum biomarkers
Time frame: 3, 6, 12 months
metabolic parameters
Time frame: 3, 6, 12 months
Maximal exercise capacity
Time frame: 12 months
Emergence of treatment-related adverse events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 24190960Belge 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.
- Background: PubMed 19389565Balligand 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.
- Background: PubMed 20933201Dessy 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.
- Derived from this study: PubMed 40121452Menghoum 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.
- Derived from this study: PubMed 37728907Balligand 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.
- Individual participant dataSharing planned: Yes. Individual participant data required to reach aims in an approved proposal, after de-identification, will be made available to investigators whose proposed use of the data has been approved by the study's Executive Committee. Proposals may be submitted up to 36 months after publication of the study results and should be directed to Jean-Luc.Balligand@uclouvain.be.
Related trials for Hypertrophy, Left Ventricular
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Balligand, Prof. MD principal investigator
Université Catholique de Louvain
10 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mirabegron, Echocardiography and Cardiac MRI in people with Hypertrophy, Left Ventricular, run by Jean-Luc Balligand at 10 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, France, Greece, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass index (LVMI) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02599480, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.