The DAPA-MEMRI Trial (DAPA-MEMRI)
Heart Failure, Diabetic Cardiomyopathies
About this trial
This is an interventional other trial for Heart Failure focused on measuring Heart failure, Sodium glucose Co-transporter 2 inhibitor therapy, Manganese enhanced cardiac magnetic resonance imaging
Eligibility 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.
Sites / Locations
- University of EdinburghRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Patients with heart failure without type 2 diabetes
Patients with heart failure with type 2 diabetes
60 patients with heart failure without type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation.
60 patients with heart failure with type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation.