Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM)
Status:
Recruiting
Trial end date:
2025-04-23
Target enrollment:
Participant gender:
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%.
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.
Phase:
Phase 4
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Hospital of Guangdong Medical University Eighth Affiliated Hospital, Sun Yat-sen University First Affiliated Hospital, Sun Yat-Sen University Jieyang People's Hospital Second Affiliated Hospital of Guangzhou Medical University Third Affiliated Hospital, Sun Yat-Sen University Yuebei People's Hospital Zhongshan People's Hospital, Guangdong, China