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

April 27, 2023 updated by: Xiao-dong Zhuang, Sun Yat-sen University

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Third Affiliated Hospital Of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510620
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guanzhou, Guangdong, China, 510260
        • Recruiting
        • The Second Affiliated Hospital of Guangzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Agree to get enrolled;
  2. Age 18-90 years old, gender is not limited;
  3. More than moderated FMR ( EROA by echocardiography ≥0.2cm2) , and LVEF more than 40%;
  4. The structure of mitral valve leaflets and chordae is normal;
  5. 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:

  1. Have indication for dapagliflozin;
  2. Angioedema, or allergic to dapagliflozin;
  3. Already taking Dapagliflozin or other SGLT2 inhibitors;
  4. Primary mitral valve structural damage, such as rheumatic heart disease, mitral valve prolapse;
  5. Non-dialysis patients with estimated glomerular filtration rate<30ml/min/1.73m2;
  6. Dialysis patients;
  7. Acute myocardial infarction, acute myocarditis, or percutaneous transluminal coronary intervention, coronary artery bypass grafting and other vascular reconstruction operations have occurred within 3 months;
  8. Those who plan to take vascular reconstruction, cardiac resynchronization therapy, percutaneous mitral valve repair, surgical valve repair or replacement within 3 months after enrollment;
  9. Complications of obvious aortic valve disease (more than moderate stenosis or more than moderate regurgitation);
  10. Thyroid function combined with hyperthyroidism has not returned to normal;
  11. Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin arm
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.
Drug: dapagliflozin
FORXIGA（Dapagliflozin Tablets), manufacturer/marketer: AstraZeneca, salt composition: Dapagliflozin (10mg), one tablet once and once a day.
No Intervention: GDMT arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitral valve effective regurgitant orifice area change
Time Frame: From baseline to 6 month
Evaluated by echocardiography at baseline and 6 month
From baseline to 6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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
Zhongshan People's Hospital, Guangdong, China
Yuebei People's Hospital
Jieyang People's Hospital
Eighth Affiliated Hospital, Sun Yat-sen University
Affiliated Hospital of Guangdong Medical University

Investigators

  • Principal Investigator: Xiaodong Zhuang, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2022

Primary Completion (Anticipated)

October 23, 2024

Study Completion (Anticipated)

April 23, 2025

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEFORM Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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