Type2 DiabetesPhase 4SGLTiNCT04200586
The Effects of SGLTi on Diabetic Cardiomyopathy
A Phase 4 study testing Dapagliflozin in people with Type2 Diabetes and Heart Failure With Reduced Ejection Fraction, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Type2 Diabetes, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Apr 2020to 30 Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of SGLT Inhibition on Diabetic Cardiomyopathy
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.
Read the 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.
- Being tested
- Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial perfusion reserve index
Change in myocardial perfusion reserve index calculated from cardiac MRI
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start9 Apr 2020
- Primary completion4 Mar 2021
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, observational
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chung-Wah David SIU, The University of Hong Kong
- Investigators
- David Chung-Wah SIU, Prof, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200586
- Sponsor's protocol ID
- Version no.3
- Acronym
- SGLTi
- Status last verified
- Aug 2021
- First submitted
- 12 Dec 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of SGLT Inhibition on Diabetic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04200586
- Acronym / sponsor ID
- SGLTi / Version no.3
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 9 Apr 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, observational
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground. | Drug | Dapagliflozin |
Primary outcome
Change in myocardial perfusion reserve index
Time frame: 8-12 weeks
Change in myocardial perfusion reserve index calculated from cardiac MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chung-Wah SIU, Prof principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Type2 Diabetes and Heart Failure With Reduced Ejection Fraction, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in myocardial perfusion reserve index (time frame: 8-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.