Investigating heart function in diabetes and heart failure patients
An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial.
This study is testing how a diabetes drug called Dapagliflozin affects heart function in people with heart failure, both with and without diabetes, to see if it helps improve their condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Edinburgh, Scotland) |
| Trial ID | NCT04591639 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how calcium handling in the heart is affected in patients with heart failure, both with and without type 2 diabetes mellitus. It involves an observational cross-sectional study comparing different patient groups and healthy volunteers using advanced cardiac MRI techniques, including manganese-enhanced imaging. Additionally, a randomized controlled trial will assess the effects of Dapagliflozin, an SGLT2 inhibitor, on myocardial calcium handling in these patients. The study seeks to uncover the mechanisms by which SGLT2 inhibitors may benefit heart failure patients.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with heart failure and/or type 2 diabetes mellitus, as well as healthy volunteers.
Not a fit: Patients without heart failure or type 2 diabetes mellitus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for heart failure patients, particularly those with diabetes.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in heart failure, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ejection fraction Healthy Volunteers * Aged over 18 years * Normal left ventricular ejection fraction and glycaemia * No clinically significant co-morbid conditions Exclusion Criteria: Patients with heart failure (with or without type 2 diabetes mellitus) * Receiving an SGLT2 inhibitor within 8 weeks of enrolment * Previous intolerance of, or contraindication to, an SGLT2 inhibitor * Standard magnetic resonance imaging safety exclusions * Severe renal impairment (eGFR \<30millilitre/min. 1.73m2) * Type 1 diabetes mellitus * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Recent (within 12 weeks) hospitalisation for heart failure, acute cardiovascular event (such as myocardial infarction or stroke) or coronary re-vascularisation. * 2nd or 3rd degree atrioventricular block Atrial fibrillation or flutter with poor ventricular rate control (\>100 /min) * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease * New York Heart Association grade IV heart failure * Obstructive liver function testing abnormalities * Concomitant digoxin, diltiazem or verapamil therapy. Patients with type 2 diabetes mellitus and no heart failure * Other major clinically significant co-morbid conditions * History of ischaemic heart disease or present history suggestive of probable clinically significant underlying ischaemic heart disease * Standard magnetic resonance imaging safety exclusions * Moderate or severe renal impairment (eGFR \<45 mL/min. 1.73m2) * Receiving a SGLT2 inhibitor at any time * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Abnormal electrocardiogram * Clinically significant abnormalities of clinical haematology or biochemistry measurements. Healthy Volunteers * Major or clinically significant cardiovascular disease * Diabetes mellitus * Receiving an SGLT2 inhibitor at any time * Standard magnetic resonance imaging safety exclusions * Moderate or severe renal impairment (eGFR \<45 mL/min. 1.73m2) * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Abnormal electrocardiogram * Clinically significant abnormalities of clinical haematology or biochemistry measurements.
Where this trial is running
Edinburgh, Scotland
- University of Edinburgh — Edinburgh, Scotland, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Shruti Joshi, MBBS, MRCP
- Email: sjoshi@ed.ac.uk
- Phone: 0131 650 1000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.