The Effects of SGLTi on Diabetic Cardiomyopathy

Sponsor
The University of Hong Kong (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04200586
Collaborator
(none)
30
1
1
17.7
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single-arm, observationalSingle-arm, observational
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of SGLT Inhibition on Diabetic Cardiomyopathy
Actual Study Start Date :
Apr 9, 2020
Actual Primary Completion Date :
Mar 4, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin

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

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

Outcome Measures

Primary Outcome Measures

  1. Change in myocardial perfusion reserve index [8-12 weeks]

    Change in myocardial perfusion reserve index calculated from cardiac MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Queen Mary Hospital Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong

Investigators

  • Principal Investigator: David Chung-Wah SIU, Prof, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Chung-Wah David SIU, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04200586
Other Study ID Numbers:
  • Version no.3
First Posted:
Dec 16, 2019
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2021