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A multi-million pound, phase 3 clinical trial (EMPA-VISION) investigating a novel drug that could help failing hearts begins at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR)

Heart failure (HF) is the inability of the heart to pump sufficient amounts of blood around the body resulting in symptoms such as shortness of breath, fatigue and swelling of the feet and legs. Since the failing heart is considered to be energy deficient, it needs additional support to pump enough blood around the body.

HF is a global epidemic affecting an estimated 26 million people worldwide and is associated with significant morbidity and mortality. However, currently there are limited available treatment options to improve outcomes and overall health of patients with HF. As such, HF remains an important public health problem.

A recent study (called EMPA-REG OUTCOME) showed that a drug called empagliflozin might help people who suffer from HF. Empagliflozin is a drug currently used to treat patients with Type 2 diabetes by removing excess glucose from the blood into the urine. Its safety has been assessed in more than 10,000 patients with Type 2 diabetes. This study has shown that people with Type 2 diabetes and HF who were treated with empagliflozin had significantly less HF-related complications.

The team in Oxford is led by Dr Masliza Mahmod and Prof Stefan Neubauer and the trial forms investigator Dr Moritz Hundertmark’s doctoral thesis. The team have combined their expertise with Boehringer Ingelheim to design this trial as part of an exciting collaboration with Boehringer Ingelheim acting as the sponsor.

The trial aims to provide a scientific explanation of the underlying mechanism by which empagliflozin improves HF related outcomes in patients with chronic HF. We think it might help the heart by enhancing its energy production and thus, improve its function.

Participants are given either empagliflozin or a dummy pill (placebo) to take, once a day, for 12 weeks. Sophisticated tests, including magnetic resonance imaging (MRI) technology before and after 12 weeks of treatment, will be used to assess participants.

The EMPA-VISION trial is the first to evaluate the effect of empagliflozin on cardiac energy metabolism in patients with heart failure. The results of this trial combined with other ongoing multicentre trials assessing clinical outcomes in patients with heart failure, could make empagliflozin a promising new treatment for patients with HF.