The Effects of SGLTi on Diabetic Cardiomyopathy
SGLTi
The Effects of SGLT Inhibition on Diabetic Cardiomyopathy
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 16, 2019
CompletedStudy Start
First participant enrolled
April 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedAugust 3, 2021
August 1, 2021
11 months
December 12, 2019
August 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in myocardial perfusion reserve index
Change in myocardial perfusion reserve index calculated from cardiac MRI
8-12 weeks
Study Arms (1)
Dapagliflozin
EXPERIMENTALDapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground
Interventions
Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- years old
- HbA1c \>= 6.5%
- history of heart failure with reduced ejection fraction
- indications for SGLT inhibition on clinical ground
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
David Chung-Wah SIU, Prof
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 16, 2019
Study Start
April 9, 2020
Primary Completion
March 4, 2021
Study Completion
September 30, 2021
Last Updated
August 3, 2021
Record last verified: 2021-08