The REFORM Trial
Research type
Research Study
Full title
Research into the Effect Of SGLT2 inhibition on left ventricular Remodelling in patients with heart failure and diabetes Mellitus
IRAS ID
161774
Contact name
Chim Lang
Contact email
Sponsor organisation
University of Dundee
Eudract number
2014-002742-42
Research summary
People with diabetes are at increased risk of developing heart failure (HF) which can lead to increased shortness of breath, reduced ability to exercise and in some cases premature death as the heart becomes less efficient at pumping blood around the body.
Drug options to treat heart failure in diabetes are currently limited as many of the drugs used are not suitable in diabetic patients as they cause unpleasant or harmful side effects.
A new class of anti-diabetic drugs may have some benefit in heart failure in diabetes as they may reduce the workload on the heart. It has been shown that they may also promote weight loss and increase exercise capacity in previous studies.
This study will test if there is a real benefit from using a drug called dapagliflozin, (a SGLT2 inhibitor), on improving the efficiency of the heart and improving exercise capacity in patients with diabetes and HF.
The findings of this study may help to find out if this class of drugs, SGLT2 inhibitors, are useful in diabetic patients with HF.In this study the aim is to recruit patients who have diabetes and heart failure.
Participants will have a Magnetic Resonance Imaging (MRI) scan of the heart, using an MRI machine, to measure the extent of thickening of the heart muscle before they start on treatment of dapagliflozin, or placebo for one year. They will also do exercise testing on an exercise bike (if capable) and a walking test plus fill in some questionnaires on how their heart failure affects their quality of life.
As this is a clinical trial the participants will be randomly allocated to either dapagliflozin or a dummy medication (placebo) so that the researchers can compare if there is a difference between normal treatment and addition of dapagliflozin. Participants will continue as normal with currently prescribed medication for their diabetes and heart failure. They will have a further MRI scan and the other tests mentioned above when their one year treatment with dapagliflozin or placebo finishes.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
14/ES/1050
Date of REC Opinion
19 Aug 2014
REC opinion
Further Information Favourable Opinion