The RECEDE-CHF Trial
Research type
Research Study
Full title
Renal and Cardiovascular Effects of SGLT2 inhibition in combination with loop diuretics in diabetic patients with chronic heart failure.
IRAS ID
210628
Contact name
Natalie Mordi
Contact email
Sponsor organisation
University of Dundee
Eudract number
2016-003968-39
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
People with diabetes are at increased risk of developing Heart Failure (HF). Symptoms of HF include 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. Many of these symptoms are caused by fluid retention.
Drug options for diabetics with HF are currently limited as many of the drugs used are not suitable. Many patients are given water tablets to help reduce or prevent fluid retention.A new class of anti-diabetic drugs may have some benefit in diabetics with HF as they may reduce workload on the heart. It has been shown that they may also promote weight loss and increase exercise capacity.
This study will test if there is any benefit from using a drug, empagliflozin, (an SGLT2 inhibitor), to boost the effects of water tablets in diabetic patients with HF, by increasing sodium and urine output. The findings of this study may help to find out if this class of drug, SGLT2 inhibitors, is useful in diabetic patients with HF.
In this study, the aim is to recruit patients who have diabetes and heart failure. Participants will undergo investigations of kidney function (renal physiological tests) by measuring urine and sodium excretion.
As this is a two-way cross over clinical trial, participants will be randomly allocated to either empagliflozin 25mg (6 weeks) or a dummy medication (placebo) (6 weeks), with a two week wash-out period between. This will allow the researchers to compare if there is a difference between normal treatment and the addition of empagliflozin. Participants will undergo renal physiological testing at week 1 and week 6 of each study arm. Participants will continue as normal with currently prescribed medication for their diabetes and heart failure.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0137
Date of REC Opinion
6 Feb 2017
REC opinion
Further Information Favourable Opinion