Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
Summary
Functional mitral regurgitation (FMR) leads to various adverse outcomes. Cardiac remodeling
(CR) and myocardial fibrosis (MF) are closely related to FMR, forming a vicious circle of
CR-FMR-MF and resulting in the end-stage heart failure (HF). The optimal therapeutic
strategies of FMR require to effectively break the vicious circle of CR-FMR-MF and still
remain full of controversy, especially in the appropriate selection of patients suitable for
transcatheter treatment. Regardless, adequate guideline-directed medical therapy (GDMT) is
always the most important therapy of FMR. Currently GDMT for FMR included β-blockers,
renin-angiotensin system (RAS) inhibitors and mineralocorticoid receptor antagonists (MRA).
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, have been proven to be effectively
in reducing cardiovascular death and worsening HF in HF patients. However, there is still no
evidence support the use of SGLT2i in FMR therapy due to the lack of relevant clinical trial.
The DEFORM trial aims to assess the efficacy of dapagliflozin in reducing the extent of
mitral regurgitation and myocardial fibrosis in FMR patients. DEFORM trial is a multi-center,
prospective, randomized, parallel controlled, investigator-initiated trial enrolling a
planned 98 FMR patients. Patients will be randomly assigned in a 1:1 ratio to either
dapagliflozin 10mg once daily for 3 months or placebo. The primary outcome is the change in
effective regurgitant orifice area (EROA) of mitral regurgitation measured by
echocardiography. Secondary end-points include change change in regurgitant volume (RV), left
ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV)
(echocardiography), change in NT-proBNP levels and occurrence of major adverse cardiac events
(MACEs).