Functional Mitral RegurgitationPhase 4DEFORMNCT05848102
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM)
A Phase 4 study testing dapagliflozin in people with Functional Mitral Regurgitation, run by Sun Yat-sen University at 3 sites in China.
Trial summary
The goal of this clinical trial is to learn about the effect of dapagliflozin on reducing the degree of mitral regurgitation and myocardial fibrosis in patients with functional mitral regurgitation (FMR) of more than moderate and left ventricular ejection fraction (LVEF) more than 40%. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 3 sitesChina
- Study dates
- 23 Dec 2022to 23 Apr 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to get enrolled;
- Age 18-90 years old, gender is not limited;
- More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%;
- The structure of mitral valve leaflets and chordae is normal;
- GDMT for FMR has been taken orally for more than 2 weeks, and the dose has not been adjusted for more than 2 weeks (If there is no contraindication, the drugs includes β blockers, the renin-angiotensin system inhibitors [Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers/angiotensin receptor neprilysin inhibitor], aldosterone receptor antagonists), and for the last 2 weeks no intravenous drug for heart failure were used.
Who cannot join
- Have indication for dapagliflozin;
- Angioedema, or allergic to dapagliflozin;
- Already taking Dapagliflozin or other SGLT2 inhibitors;
- Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse;
- Non-dialysis patients with estimated glomerular filtration rate<30ml/min/1.73m2;
- Dialysis patients;
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- Acute myocardial infarction, acute myocarditis, or percutaneous transluminal coronary intervention, coronary artery bypass grafting and other vascular reconstruction operations have occurred within 3 months;
- Those who plan to take vascular reconstruction, cardiac resynchronization therapy, percutaneous mitral valve repair, surgical valve repair or replacement within 3 months after enrollment;
- Complications of obvious aortic valve disease (more than moderate stenosis or more than moderate regurgitation);
- Thyroid function combined with hyperthyroidism has not returned to normal;
- Pregnant and lactating women.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Zhuoshan Huang, Dr, 86 85252168, huangzhsh3@mail.sysu.edu.cn
- Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510620
Xiaodong Zhuang, Dr, +86 02087338190, zhuangxd3@mail.sysu.edu.cn
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 510260
Longgen Xiong, PhD, (+86)15914338759, xionglg66@126.com
About this study
Official title: Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM): a Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn about the effect of dapagliflozin on reducing the degree of mitral regurgitation and myocardial fibrosis in patients with functional mitral regurgitation (FMR) of more than moderate and left ventricular ejection fraction (LVEF) more than 40%.
The main question[s] it aims to answer are:
Read more
- For FMR patients with EF>40%, whether adding SGLT2 to guideline directed medical therapy (GDMT) can reduce MR degree and myocardial fibrosis, as well as improve patient's cardio-pulmonary function and quality of life is unknown.
- For FMR patients with EF>40%, whether adding SGLT2 to GDMT can decelerate the progression of FMR to end-stage heart failure, reduce the demand for percutaneous mitral valve repair and improve the prognosis is unknown.
Participants in dapagliflozin arm will add dapagliflozin of 10 mg/d orally for 6 months on the basis of regular GDMT for FMR. Researchers will compare the dapagliflozin arm to the GDMT arm who only accept the regular GDMT to see if the effective regurgitant orifice area was decreased.
The primary endpoint was the effective regurgitant orifice area(EROA) change from baseline to 6 months.
The secondary endpoints include the cardiac magnetic resonance assessment of myocardial fibrosis, the N-terminal fragment of the pro brain natriuretic peptides(NT-pro BNP), maximal exercise capacity by cardiopulmonary exercise testing, distance in the 6 minutes walking test, Kansas City cardiomyopathy questionnaire and Cardiovascular events.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- dapagliflozin
- Keywords
- dapagliflozin, Guideline directed medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapagliflozinDrug
FORXIGA（Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin arm | Experimental | In the Dapagliflozin arm, participants with functional mitral regurgitation of more than moderate and left ventricular ejection fraction of more than 40% will add oral drug of Forxiga (Dapagliflozin, specification: 10mg) of 10 mg per day on the basis of regular guideline directed medical therapy for functional mitral regurgitation for 6 months. Receives: Drug: dapagliflozin |
| GDMT arm | No intervention | In the guideline directed medical therapy (GDMT) arm, participants with functional mitral regurgitation of more than moderate and left ventricular ejection fraction of more than 40% will continue to maintain the original treatment of GDMT for 6 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitral valve effective regurgitant orifice area change
Evaluated by echocardiography at baseline and 6 month
Measured: From baseline to 6 month
Secondary outcomes (5)
myocardial fibrosis change
Evaluated by cardiac magnetic resonance
Measured: from baseline to 6 month
NT-proBNP change
N-terminal pro-brain natriuretic peptide(NT-proBNP) tested in Venous blood sample
Measured: from baseline to 6 month
KCCQ-12 score
Cardiomyopathy questionnaire (Kansas City):(KCCQ-12)
Measured: from baseline to 6 month
cardiopulmonary exercise testing score
Cardiorespiratory functional assessment
Measured: from baseline to 6 month
Distance of 6 minutes walking test
Measured: from baseline to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start23 Dec 2022
- Primary completion23 Oct 2024 (estimated)
- Study completion23 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Jieyang People's Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, Yuebei People's Hospital, Zhongshan People's Hospital, Guangdong, China
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- Xiaodong Zhuang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848102
- Sponsor's protocol ID
- DEFORM Study
- Acronym
- DEFORM
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM): a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05848102
- Acronym / sponsor ID
- DEFORM / DEFORM Study
- Conditions
- Functional Mitral Regurgitation
- Keywords
- dapagliflozin, Guideline directed medical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Jieyang People's Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, Yuebei People's Hospital, Zhongshan People's Hospital, Guangdong, China
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 23 Oct 2024 (estimated)
- Study completion
- 23 Apr 2025 (estimated)
- First posted
- 8 May 2023 (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.
The goal of this clinical trial is to learn about the effect of dapagliflozin on reducing the degree of mitral regurgitation and myocardial fibrosis in patients with functional mitral regurgitation (FMR) of more than moderate and left ventricular ejection fraction (LVEF) more than 40%.
The main question[s] it aims to answer are:
- For FMR patients with EF>40%, whether adding SGLT2 to guideline directed medical therapy (GDMT) can reduce MR degree and myocardial fibrosis, as well as improve patient's cardio-pulmonary function and quality of life is unknown.
- For FMR patients with EF>40%, whether adding SGLT2 to GDMT can decelerate the progression of FMR to end-stage heart failure, reduce the demand for percutaneous mitral valve repair and improve the prognosis is unknown.
Participants in dapagliflozin arm will add dapagliflozin of 10 mg/d orally for 6 months on the basis of regular GDMT for FMR. Researchers will compare the dapagliflozin arm to the GDMT arm who only accept the regular GDMT to see if the effective regurgitant orifice area was decreased.
The primary endpoint was the effective regurgitant orifice area(EROA) change from baseline to 6 months.
The secondary endpoints include the cardiac magnetic resonance assessment of myocardial fibrosis, the N-terminal fragment of the pro brain natriuretic peptides(NT-pro BNP), maximal exercise capacity by cardiopulmonary exercise testing, distance in the 6 minutes walking test, Kansas City cardiomyopathy questionnaire and Cardiovascular events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin arm | Experimental | Drug: dapagliflozinIn the Dapagliflozin arm, participants with functional mitral regurgitation of more than moderate and left ventricular ejection fraction of more than 40% will add oral drug of Forxiga (Dapagliflozin, specification: 10mg) of 10 mg per day on the basis of regular guideline directed medical therapy for functional mitral regurgitation for 6 months. |
| GDMT arm | No intervention | –In the guideline directed medical therapy (GDMT) arm, participants with functional mitral regurgitation of more than moderate and left ventricular ejection fraction of more than 40% will continue to maintain the original treatment of GDMT for 6 month. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Agree to get enrolled;
- Age 18-90 years old, gender is not limited;
- More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%;
- The structure of mitral valve leaflets and chordae is normal;
- GDMT for FMR has been taken orally for more than 2 weeks, and the dose has not been adjusted for more than 2 weeks (If there is no contraindication, the drugs includes β blockers, the renin-angiotensin system inhibitors [Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers/angiotensin receptor neprilysin inhibitor], aldosterone receptor antagonists), and for the last 2 weeks no intravenous drug for heart failure were used.
Key exclusion criteria (11 listed)
- Have indication for dapagliflozin;
- Angioedema, or allergic to dapagliflozin;
- Already taking Dapagliflozin or other SGLT2 inhibitors;
- Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse;
- Non-dialysis patients with estimated glomerular filtration rate<30ml/min/1.73m2;
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 |
|---|---|---|
| dapagliflozinFORXIGA（Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day. | Drug | Dapagliflozin arm |
Primary outcome
Mitral valve effective regurgitant orifice area change
Time frame: From baseline to 6 month
Evaluated by echocardiography at baseline and 6 month
5 secondary outcomes
myocardial fibrosis change
Time frame: from baseline to 6 month
NT-proBNP change
Time frame: from baseline to 6 month
KCCQ-12 score
Time frame: from baseline to 6 month
cardiopulmonary exercise testing score
Time frame: from baseline to 6 month
Distance of 6 minutes walking test
Time frame: from baseline to 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: No
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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.
Xiaodong Zhuang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
3 sites 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 Functional Mitral Regurgitation, run by Sun Yat-sen University at 3 sites in China.
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 11 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 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Contact Xiaodong Zhuang, PhD ((+86)13760755035, zhuangxd3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitral valve effective regurgitant orifice area change (time frame: From baseline to 6 month). 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 8 May 2023.