EMPA-VISION
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, mechanistic cardiac magnetic resonance study to investigate the effects of empagliflozin treatment on cardiac physiology and metabolism in patients with heart failure
IRAS ID
224989
Contact name
Elena Villarreal
Contact email
Sponsor organisation
Boehringer Ingelheim Limited
Eudract number
2017-000376-28
Duration of Study in the UK
1 years, 7 months, 17 days
Research summary
Research has suggested that empagliflozin may improve the health of people with heart failure and so could be a possible treatment for this condition. We hope to understand how empagliflozin might do this by using the latest imaging technology to look at the heart.
Empagliflozin belongs to a group of drugs known as SGLT-2 inhibitors. SGLT-2 stands for sodium glucose co-transporter 2. Empagliflozin is currently used to treat type 2 diabetes as it causes glucose to be removed from the body in the urine and therefore reduces blood sugar levels.
Participants have been diagnosed with heart failure, either with a reduced (Group A) or preserved (Group B) ejection fraction (the amount of blood pumped out of the ventricles of the heart on each contraction). Forty three people will be enrolled in each group at a single site based at the University of Oxford Centre for Clinical Magnetic Resonance Research (OCMR).
Participants will first undergo screening assessment to confirm they are eligible to take part. This will include a CT scan to assess if there is any significant coronary artery stenosis (narrowing) and an ultrasound of the heart to assess its function. If eligible, participants will be treated with either 10mg tablets of empagliflozin or matching placebo for 12 weeks.
Assessments to monitor heart function will be undertaken before and after the treatment period. These tests include an electrocardiogram (ECG), echocardiogram (ECHO), exercise tests and a magnetic resonance imaging (MRI) of the heart. Participants will also complete quality of life questionnaires and be monitored for any side-effects of the treatment. A final follow-up phone call will take place one to two weeks after treatment has finished.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0262
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion