The Effects of SGLTi on Diabetic Cardiomyopathy

• Status: Active, not recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Diabetic cardiomyopathy is associated with significant morbidity and mortality. It is considered as a cardiac muscle disorder secondary to diabetes mellitus (DM). Certain studies show the clinical benefit of SGLT-s inhibitors on reducing cardiovascular outcomes amongst patients with type II DM that go beyond the correction of hyperglycemic perse. Thus an observational imaging study is proposed to identify mechanistic insights of the drug group over cardiovascular events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

• type 2 diabetes

• 40-90 years old

• HbA1c >= 6.5%

• history of heart failure with reduced ejection fraction

• indications for SGLT inhibition on clinical ground

Exclusion Criteria:

• angina pectoris or chest discomfort

• prior coronary artery bypass grafts

• coronary artery stenting within 6 months of study enrolment

• pervious myocardial infarct

• any contraindication for stress CMR testing

• renal impairment with eGFR <45ml/min/1.73m2

• limited life expectancy <5 years, for example due to pulmonary disease, cancer or

• significant hepatic failure

• contraindication to dapagliflozin or other SGLT2 inhibitors

• unable to take dapagliflozin

• patients currently on and SGLT2 inhibitor

• planned need for concomitant cardiac surgery or coronary intervention

• refusal or inability to sign an informed consent

• potential for on-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits