SGLT2 Inhibition in Combination With Diuretics in Heart Failure (NCT03226457) | Clinical Trial Compass
CompletedPhase 4
SGLT2 Inhibition in Combination With Diuretics in Heart Failure
United Kingdom23 participantsStarted 2017-12-11
Plain-language summary
The RECEDE-CHF trial is a single centre phase IV, randomised, double-blind, placebo-controlled, crossover trial conducted in NHS Tayside, Scotland comparing empagliflozin 25mg, to placebo in patients with Type 2 Diabetes and mild Chronic Heart Failure with left ventricular systolic dysfunction who are already on a loop diuretic. Renal physiological testing will be performed at two points on each arm to assess the effect of empagliflozin, on urinary volume, compared to placebo. The secondary outcomes are to assess the effect of empagliflozin in addition to loop diuretics on natriuresis, to assess the safety of add-on SGLT2 inhibitor therapy as measured by changes to serum creatinine and eGFR, to assess effects of empagliflozin on urinary protein/creatinine ratio, albumin/creatinine ratio and cystatin C when compared to placebo.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of NYHA Functional class II-III HF with prior echocardiographic evidence of LVSD.
* On stable doses of furosemide, or alternative loop diuretic for at least one month.
* Stable Type 2 Diabetes (HbA1c, in the last 3 months, of 6.5% ≤ and ≤10.0%)
* eGFR ≥ 45 ml/min.
* Have stable HF symptoms for at least three months prior to consent
* On stable HF therapy for at least three months prior to consent
* Have not been hospitalised for HF for at least three months prior to consent.
* Women of childbearing potential must agree to take precautions to avoid pregnancy throughout the trial and for 4 weeks after intake of the last dose.
Exclusion Criteria:
* A diagnosis of chronic liver disease and/or liver enzymes that are twice the upper limit of normal
* Systolic BP of \<95mmHg at screening visit.
* Participants on thiazide diuretics.
* Participants receiving renal dialysis
* Participants who have previously had an episode of diabetic ketoacidosis.
* Participants with type 1 diabetes mellitus
* Malignancy (receiving active treatment) or other life threatening disease.
* Pregnant or lactating women
* Participants with difficulty in micturition e.g. severe prostate enlargement
* Allergy to any SGLT2 inhibitor or lactose or galactose intolerance
* Past or current treatment with any SGLT2 inhibitor
* Participants who have participated in any other clinical interventional trial of an investigational medicinal product within 30 days.
* Participants who are …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Effect of Empagliflozin Versus Placebo on the Change in Urine Output.