The DAPA-MEMRI Trial
Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across t
| Condition(s) | Heart Failure, Diabetic Cardiomyopathies |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across the heart muscle and disruption of this process is an early change seen in heart failure. Recently, a drug therapy (SGLT2 inhibitor therapy) in patients with diabetes was shown to benefit patients with heart failure but the mechanisms of benefit are unknown. Our hypothesis is that calcium handling is altered in patients with either type 2 diabetes mellitus (T2DM) or heart failure and that SGLT2 inhibitors can improve this in heart failure irrespective of the presence of T2DM. |
| Who can participate | Inclusion Criteria: Patients with heart failure (with or without type 2 diabetes mellitus) * Aged over 18 years * Diagnosis of symptomatic reduced ejection fraction heart failure for at least 2 months * Left ventricular ejection fraction ≤40% * Elevated N-terminal pro B-type natriuretic peptide (\>125 pg/mL) * Clinical diagnosis of type 2 diabetes mellitus for 50% of patient population - on stable therapy for at least 12 months or more. Patients with Type 2 Diabetes Mellitus and no heart failure * Aged over 18 years * Clinical diagnosis of type 2 diabetes mellitus (diagnosed by either HbA1c of 48mmol/mol (6.5%) or greater or fasting plasma glucose level of 7mmol/L or greater at the time of diagnosis) \- on stable therapy for at least 12 months or more. * Normal left ventricular systolic ej |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Edinburgh |
| Locations | Edinburgh, Scotland, United Kingdom |
| Start date | 2020-08-19 |
| NCT ID | NCT04591639 |
| Official listing | https://clinicaltrials.gov/study/NCT04591639 |