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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
166
FORXIGA(Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day.
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, China
RECRUITINGMitral valve effective regurgitant orifice area change
Evaluated by echocardiography at baseline and 6 month
Time frame: From baseline to 6 month
myocardial fibrosis change
Evaluated by cardiac magnetic resonance
Time frame: from baseline to 6 month
NT-proBNP change
N-terminal pro-brain natriuretic peptide(NT-proBNP) tested in Venous blood sample
Time frame: from baseline to 6 month
KCCQ-12 score
Cardiomyopathy questionnaire (Kansas City):(KCCQ-12)
Time frame: from baseline to 6 month
cardiopulmonary exercise testing score
Cardiorespiratory functional assessment
Time frame: from baseline to 6 month
Distance of 6 minutes walking test
Time frame: from baseline to 6 month
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