UnknownPhase 4

The Effects of SGLTi on Diabetic Cardiomyopathy

Hong Kong30 participantsStarted 2020-04-09

Plain-language 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.

Who can participate

Age range

40 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in myocardial perfusion reserve index

Timeframe: 8-12 weeks

Trial details

NCT IDNCT04200586

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-04

View on ClinicalTrials.gov More Type2 Diabetes trials