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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | FORXIGA(Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mitral valve effective regurgitant orifice area change | Evaluated by echocardiography at baseline and 6 month | From baseline to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| myocardial fibrosis change | Evaluated by cardiac magnetic resonance | from baseline to 6 month |
| NT-proBNP change | N-terminal pro-brain natriuretic peptide(NT-proBNP) tested in Venous blood sample |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Zhuang, PhD | Contact | (+86)13760755035 | zhuangxd3@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaodong Zhuang, PhD | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Jieyang People's Hospital | OTHER |
| Eighth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Affiliated Hospital of Guangdong Medical University | OTHER |
| Yuebei People's Hospital | OTHER |
| Zhongshan People's Hospital, Guangdong, China | OTHER |
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| from baseline to 6 month |
| KCCQ-12 score | Cardiomyopathy questionnaire (Kansas City):(KCCQ-12) | from baseline to 6 month |
| cardiopulmonary exercise testing score | Cardiorespiratory functional assessment | from baseline to 6 month |
| Distance of 6 minutes walking test | from baseline to 6 month |
| The First Affiliated Hospital of Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510620 | China |
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| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guanzhou | Guangdong | 510260 | China |
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