BETA3_LVH · Project

Repurposing an Existing Drug to Treat Heart Failure Before It Strikes

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Millions of older adults — especially women with high blood pressure or obesity — develop a type of heart failure where the heart muscle gets too stiff and thick to pump properly. Right now, doctors have no specific drug to stop this from happening. This project took mirabegron, a medicine already sold for bladder problems, and ran a large clinical trial across 8 countries to see if it could also shrink thickened heart muscle and improve heart function. The idea is like finding out an existing tool in your garage also fixes a completely different problem — saving years of drug development time.

By the numbers

consortium partners in clinical trial

countries participating in the trial

12 months

treatment duration in the clinical trial

project deliverables produced

industrial partner in consortium

The business problem

What needed solving

Heart failure with preserved ejection fraction affects millions of elderly patients — predominantly women with hypertension and obesity — and currently has no specific approved treatment beyond managing risk factors. Pharma companies face a costly paradox: developing new cardiac drugs from scratch takes over a decade and billions in investment, while a potentially effective molecule (mirabegron) already sits on pharmacy shelves approved for a different condition.

The solution

What was built

The project conducted a multi-center, randomized, placebo-controlled clinical trial testing mirabegron for structural heart disease across 8 European countries with 20 partner institutions over 12 months. Deliverables include the clinical trial data on cardiac MRI, echocardiography, exercise tolerance, and biomarker outcomes, plus a functional public website documenting the trial.

Audience

Who needs this

Pharmaceutical companies with cardiovascular pipelines seeking drug repurposing opportunitiesCardiology device manufacturers developing heart failure monitoring and diagnostic toolsContract research organizations specializing in multi-center European clinical trialsHealth insurers and payers evaluating preventive treatments for heart failureBiotech companies developing beta3-adrenergic receptor therapies

Business applications

Who can put this to work

Pharmaceutical & Drug Repurposing

enterprise

Target: Pharma companies with cardiovascular pipelines or drug repurposing programs

If you are a pharmaceutical company looking to expand indications for existing drugs — this project ran a multi-center, randomized, placebo-controlled clinical trial across 8 countries with 20 partner institutions testing mirabegron for structural heart disease. The trial data on cardiac MRI outcomes, echocardiography, and exercise tolerance could support a new indication filing or licensing deal for cardiovascular use of beta3-adrenergic receptor agonists.

Medical Devices & Cardiac Imaging

mid-size

Target: Companies making cardiac MRI or echocardiography equipment

If you are a cardiac imaging company seeking validated clinical protocols — this trial used quantitative cardiac MRI to measure myocardial hypertrophy changes and Doppler echocardiography for diastolic function over 12 months. These standardized measurement protocols across 20 partner sites could become reference standards for future heart failure prevention trials, creating demand for your imaging solutions.

Digital Health & Clinical Trials

mid-size

Target: CROs and digital health companies supporting multi-center trials

If you are a contract research organization or clinical trial platform provider — this project coordinated a multi-center trial across 8 countries involving 20 institutions, managing complex endpoints including cardiac MRI, echocardiography, exercise testing, and circulating biomarkers. The operational model and data infrastructure built here represent proven templates for running cardiovascular prevention trials at European scale.

Frequently asked

Quick answers

What would it cost to license or build on this research?

The project did not publish licensing terms or cost data. Mirabegron is an existing approved drug (for overactive bladder), so manufacturing costs are already established. A pharma company interested in pursuing a cardiovascular indication would need to negotiate with the consortium and potentially the original mirabegron patent holder for rights to the clinical trial data.

Can this scale to industrial or commercial use?

Mirabegron is already manufactured at commercial scale for its bladder indication. The cardiovascular application would require regulatory approval for the new indication based on the clinical trial results from this 20-partner, 8-country study. Scaling the treatment itself is straightforward since the drug already exists on the market.

What is the IP and licensing situation?

The clinical trial data and protocols are owned by the consortium led by Université Catholique de Louvain in Belgium. Mirabegron itself is patented by Astellas Pharma for bladder use. Any company pursuing the cardiovascular indication would need to navigate both the original drug IP and the new clinical evidence generated by this project.

What regulatory approvals would be needed?

A new indication for mirabegron in structural heart disease would require a supplemental regulatory filing with EMA and/or FDA. The project generated 12-month randomized controlled trial data with cardiac MRI and echocardiography endpoints, which is the type of evidence regulators expect. Additional Phase III trials may be required depending on the results.

How long before this could reach patients commercially?

The trial ran from 2015 to 2022 and is now closed. If results are positive, a pharma partner could pursue a new indication filing, which typically takes 2-4 years for regulatory review. Since mirabegron is already manufactured and distributed, the supply chain infrastructure already exists.

How does this integrate with existing cardiac care?

The trial tested mirabegron on top of standard treatment for patients with structural heart disease without overt heart failure. This means it was designed as an add-on therapy, not a replacement, making integration into existing cardiology practice relatively straightforward if approved.

Consortium

Who built it

The BETA3_LVH consortium is heavily academic, with 10 universities and 3 research organizations forming the core — exactly what you'd expect for a clinical trial. Only 1 industrial partner (5% industry ratio) participated across the 20-member, 8-country consortium. This means the clinical expertise and trial data are strong, but commercial translation will require new pharma industry partnerships. The coordinator is Université Catholique de Louvain in Belgium, a major European research university. The geographic spread across Belgium, Germany, Greece, France, Italy, Poland, Portugal, and the UK provides diverse patient population data that strengthens the regulatory case for any future drug approval filing.

UNIVERSITE CATHOLIQUE DE LOUVAINCoordinator · BE
ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORKparticipant · FR
AZIENDA OSPEDALIERA PAPA GIOVANNI XXIIIparticipant · IT
KLINIKUM DER UNIVERSITAET ZU KOELNthirdparty · DE
ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINONparticipant · EL
SOCIETE EUROPEENNE DE CARDIOLOGIEparticipant · FR
Associação para Investigação e Desenvolvimento da Faculdade de Medicinaparticipant · PT
CLINIQUES UNIVERSITAIRES SAINT-LUC ASBLthirdparty · BE
UNIVERSITAET LEIPZIGparticipant · DE
CHARITE - UNIVERSITAETSMEDIZIN BERLINparticipant · DE
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORDparticipant · UK
FONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DE BERGAMOthirdparty · IT
UNIVERSITAETSMEDIZIN GOETTINGEN - GEORG-AUGUST-UNIVERSITAET GOETTINGEN - STIFTUNG OEFFENTLICHEN RECHTSparticipant · DE
UNIWERSYTET MEDYCZNY IM PIASTOW SLASKICH WE WROCLAWIUparticipant · PL
CENTRE HOSPITALIER UNIVERSITAIRE DE NANTESparticipant · FR
KKS-NETZWERK EV -NETZWERK DER KOORDINIERUNGSZENTREN FUR KLINISCHE STUDIENthirdparty · DE
UNIVERSITATKLINIKUM LEIPZIGthirdparty · DE

How to reach the team

Université Catholique de Louvain, Belgium — contact available through SciTransfer

Order a report on this consortium See UNIVERSITE CATHOLIQUE DE LOUVAIN profile →

Next steps

Talk to the team behind this work.

Want access to the BETA3_LVH clinical trial findings or an introduction to the research team? SciTransfer can arrange a briefing and facilitate connection with the consortium coordinator.

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