| NCT ID | NCT04591639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-08-19 |
| Primary Completion | 2028-07-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2020-08-19 with a primary completion date of 2028-07-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function by using a new contrast 'dye' containing manganese that has shown advantages over traditional contrast. We plan to further test this new dye as it has the potential to track and quantify improvements in heart function over time and detect changes in calcium handling in the heart muscle, making it an ideal measure to identify the mechanisms of benefit from SGLT2 inhibitor therapy. The study population will comprise patients with heart failure with and without type 2 diabetes, patients with type 2 diabetes without heart failure and healthy volunteers. Baseline comparisons will be made between the four groups before progressing to the randomised controlled trial with heart failure patients only. Patients will have a clinical assessment and blood tests, electrocardiogram, echocardiogram and MRI of the heart at each visit. If successful, this study will give us significant insights into mechanisms of action of SGLT2 inhibitors in heart failure and will enable us to tailor specific treatments in heart failure patients.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04591639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04591639 currently recruiting?
Yes, NCT04591639 is actively recruiting participants. Contact the research team at sjoshi@ed.ac.uk for enrollment information.
Where is the NCT04591639 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom.
Who is sponsoring the NCT04591639 clinical trial?
NCT04591639 is sponsored by University of Edinburgh. The trial plans to enroll 160 participants.
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