The Effects of SGLTi on Diabetic Cardiomyopathy

NCT ID: NCT04200586

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-09
• Study Completion Date: 2021-09-30

Brief 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.

Detailed Description

Diabetic cardiomyopathy is defined as ventricular dysfunction in diabetic patients in the absence of coronary artery disease and hypertension. It is considered as a cardiac muscle disorder due to the metabolic consequences of DM characterized by left ventricular hypertrophy, left ventricular diastolic dysfunction (in the early stage), and/or systolic dysfunction. To date, there is no specific treatment proven effective for the condition due to the incomplete understanding of the pathogenesis.

Recent studies however prove the efficacy of SGLT-2 inhibitors on reducing the primary composite end point of cardiovascular outcomes including hospitalization for heart failure, cardiovascular death, and all-cause death amongst patients with type II DM. Such clinical benefit is apparently mainly stemmed from the reduction in heart failure related mortality and sudden cardiac death rather than the macro-vascular events such as myocardial infarct and stroke, suggesting addition benefits going beyond the correction of hyperglycemia perse. These studies thus raise the possibility that the drug may have direct effects on the myocardium that conferring the clinical benefit not related the modification of traditional risk factors such as glycemic control, lipid, blood pressure, and obesity.

A single-arm, observational cardiac magnetic resonance imaging study is proposed in type II diabetic patients before and 2 months after initiation of dapagliflozin. The aim is to identify mechanistic insights leading to the unexpected clinical benefit of SGLT inhibition.

Conditions

Type2 Diabetes; Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dapagliflozin

Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.

Interventions

Dapagliflozin

Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chung-Wah David SIU

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Chung-Wah SIU, Prof

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

Version no.3

Identifier Type: -

Identifier Source: org_study_id