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

Primary Purpose

Functional Mitral Regurgitation

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
dapagliflozin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring dapagliflozin, Guideline directed medical therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Agree to get enrolled; Age 18-90 years old, gender is not limited; More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%; The structure of mitral valve leaflets and chordae is normal; GDMT for FMR has been taken orally for more than 2 weeks, and the dose has not been adjusted for more than 2 weeks (If there is no contraindication, the drugs includes β blockers, the renin-angiotensin system inhibitors [Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers/angiotensin receptor neprilysin inhibitor], aldosterone receptor antagonists), and for the last 2 weeks no intravenous drug for heart failure were used. Exclusion Criteria: Have indication for dapagliflozin; Angioedema, or allergic to dapagliflozin; Already taking Dapagliflozin or other SGLT2 inhibitors; Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse; Non-dialysis patients with estimated glomerular filtration rate<30ml/min/1.73m2; Dialysis patients; Acute myocardial infarction, acute myocarditis, or percutaneous transluminal coronary intervention, coronary artery bypass grafting and other vascular reconstruction operations have occurred within 3 months; Those who plan to take vascular reconstruction, cardiac resynchronization therapy, percutaneous mitral valve repair, surgical valve repair or replacement within 3 months after enrollment; Complications of obvious aortic valve disease (more than moderate stenosis or more than moderate regurgitation); Thyroid function combined with hyperthyroidism has not returned to normal; Pregnant and lactating women.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
  • The First Affiliated Hospital of Sun Yat-Sen UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dapagliflozin arm

GDMT arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mitral valve effective regurgitant orifice area change
Evaluated by echocardiography at baseline and 6 month

Secondary Outcome Measures

myocardial fibrosis change
Evaluated by cardiac magnetic resonance
NT-proBNP change
N-terminal pro-brain natriuretic peptide(NT-proBNP) tested in Venous blood sample
KCCQ-12 score
Cardiomyopathy questionnaire (Kansas City):(KCCQ-12)
cardiopulmonary exercise testing score
Cardiorespiratory functional assessment
Distance of 6 minutes walking test

Full Information

First Posted
April 13, 2023
Last Updated
April 27, 2023
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Jieyang People's Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, Yuebei People's Hospital, Zhongshan People's Hospital, Guangdong, China
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1. Study Identification

Unique Protocol Identification Number
NCT05848102
Brief Title
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM)
Acronym
DEFORM
Official Title
Dapagliflozin Effect on FunctiOnal Mitral Regurgitation and Myocardial Fibrosis (DEFORM): a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2022 (Actual)
Primary Completion Date
October 23, 2024 (Anticipated)
Study Completion Date
April 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University, Jieyang People's Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Guangdong Medical University, Yuebei People's Hospital, Zhongshan People's Hospital, Guangdong, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation
Keywords
dapagliflozin, Guideline directed medical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin arm
Arm Type
Experimental
Arm Description
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.
Arm Title
GDMT arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
dapagliflozin
Intervention Description
FORXIGA（Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day.
Primary Outcome Measure Information:
Title
Mitral valve effective regurgitant orifice area change
Description
Evaluated by echocardiography at baseline and 6 month
Time Frame
From baseline to 6 month
Secondary Outcome Measure Information:
Title
myocardial fibrosis change
Description
Evaluated by cardiac magnetic resonance
Time Frame
from baseline to 6 month
Title
NT-proBNP change
Description
N-terminal pro-brain natriuretic peptide(NT-proBNP) tested in Venous blood sample
Time Frame
from baseline to 6 month
Title
KCCQ-12 score
Description
Cardiomyopathy questionnaire (Kansas City):(KCCQ-12)
Time Frame
from baseline to 6 month
Title
cardiopulmonary exercise testing score
Description
Cardiorespiratory functional assessment
Time Frame
from baseline to 6 month
Title
Distance of 6 minutes walking test
Time Frame
from baseline to 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agree to get enrolled; Age 18-90 years old, gender is not limited; More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%; The structure of mitral valve leaflets and chordae is normal; GDMT for FMR has been taken orally for more than 2 weeks, and the dose has not been adjusted for more than 2 weeks (If there is no contraindication, the drugs includes β blockers, the renin-angiotensin system inhibitors [Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers/angiotensin receptor neprilysin inhibitor], aldosterone receptor antagonists), and for the last 2 weeks no intravenous drug for heart failure were used. Exclusion Criteria: Have indication for dapagliflozin; Angioedema, or allergic to dapagliflozin; Already taking Dapagliflozin or other SGLT2 inhibitors; Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse; Non-dialysis patients with estimated glomerular filtration rate<30ml/min/1.73m2; Dialysis patients; Acute myocardial infarction, acute myocarditis, or percutaneous transluminal coronary intervention, coronary artery bypass grafting and other vascular reconstruction operations have occurred within 3 months; Those who plan to take vascular reconstruction, cardiac resynchronization therapy, percutaneous mitral valve repair, surgical valve repair or replacement within 3 months after enrollment; Complications of obvious aortic valve disease (more than moderate stenosis or more than moderate regurgitation); Thyroid function combined with hyperthyroidism has not returned to normal; Pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Zhuang, PhD
Phone
(+86)13760755035
Email
zhuangxd3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhuang, PhD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoshan Huang, Dr
Phone
86 85252168
Email
huangzhsh3@mail.sysu.edu.cn
Facility Name
The First Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510620
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhuang, Dr
Phone
+86 02087338190
Email
zhuangxd3@mail.sysu.edu.cn
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Longgen Xiong, PhD
Phone
(+86)15914338759
Email
xionglg66@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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