Clinical Trials Logo
  1. Home
  2. Functional Mitral Regurgitation
  3. NCT05848102

Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM) — DEFORM  

Functional Mitral Regurgitation Clinical Trial

Official title:
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM): a Multicenter Randomized Controlled Trial

Clinical 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%. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05848102
Study type Interventional
Source Sun Yat-sen University
Contact Xiaodong Zhuang, PhD
Phone (+86)13760755035
Email zhuangxd3@mail.sysu.edu.cn
Status Recruiting
Phase Phase 4
Start date December 23, 2022
Completion date April 23, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT02520310 - AVJ-514 Japan Trial N/A
Not yet recruiting NCT04396379 - Epicardial Mitral Touch System for Mitral Insufficiency N/A
Not yet recruiting NCT05566340 - Treatment of Moderate FMR During AVR
Completed NCT01899573 - Percutaneous Left Ventricular Reshaping to Reduce Functional Mitral Regurgitation and Improve LV Function N/A
Terminated NCT04529928 - An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation N/A
Recruiting NCT03706833 - Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial N/A
Completed NCT00800046 - A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study N/A
Active, not recruiting NCT03929913 - NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility Study N/A
Active, not recruiting NCT05988450 - Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation N/A
Recruiting NCT03616678 - VenTouch OUS Feasibility Study N/A
Not yet recruiting NCT04679714 - EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation N/A
Active, not recruiting NCT02701972 - Evaluation of Safety and Efficacy of the BACE™ Device in the Treatment of Functional Mitral Valve Regurgitation [FMR N/A
Enrolling by invitation NCT04776798 - Biomechanical Taping on Low Back Pain With Increased Foot Pronation N/A
Enrolling by invitation NCT05677568 - The CINCH-FMR Post-Market Registry: Percutaneous Repair in Functional Mitral Regurgitation
Recruiting NCT03433274 - Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation N/A
Completed NCT05865938 - PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge Repair
Terminated NCT03016975 - Edwards Cardioband System ACTIVE Pivotal Clinical Trial (ACTIVE) N/A
Completed NCT02471664 - Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation N/A
Active, not recruiting NCT02671799 - Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR) N/A
Recruiting NCT03142152 - The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR N/A