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Effect of Dapagliflozin on Secondary Mitral Regurgitation

Primary Purpose

Dilated Cardiomyopathy

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Dapagliflozin Farxiga®
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients ≥ 18 years of age Dilated LV with a reduced ejection fraction and secondary functional MR NYHA functional class II or III Moderate to Severe MR which lasted > 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB) Exclusion Criteria: Current use or prior use of Dapagliflozin Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study NYHA functional class IV Chronic renal impairment with GFR < 30 mL/min/1.73m2 Pregnant or lactating women History of allergy to Dapagliflozin

Sites / Locations

  • Beni-suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Interventional

Arm Description

Group 1 received only standard therapy ACE/ ARB, BB, and diuretics

Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics

Outcomes

Primary Outcome Measures

Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
Change in median / mean of EROA before and after drug administration

Secondary Outcome Measures

Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients
Change in median / mean of ProBNP before and after drug administration

Full Information

First Posted
April 27, 2023
Last Updated
May 7, 2023
Sponsor
October 6 University
Collaborators
Beni-Suef University, National Heart Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05849766
Brief Title
Effect of Dapagliflozin on Secondary Mitral Regurgitation
Official Title
Effect of Dapagliflozin on Secondary Mitral Regurgitation in Patients With Left Ventricular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Beni-Suef University, National Heart Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A significant reduction in the incidence of CV death or hospitalization for HF has been observed in randomized trials investigating the CV benefit of Dapagliflozin. Mechanistic investigations are required to interpret the positive clinical effects of Dapagliflozin on heart structure and valvular regurgitation.
Detailed Description
A functional mitral regurgitation (MR) occurs when the mitral valve (MV) becomes tethered due to abnormal LV remodelling in individuals with heart failure (HF) and left ventricular (LV) dilatation. The primary treatment for HF is medical, and it is based on established guidelines, as LV failure is the most common cause of secondary functional MR. Standard medical therapy for patients with functional MR, including beta blockers, ACE inhibitors, and angiotensin receptor blockers (ARB), does not reduce the morbidity or mortality associated with these conditions. Similar to the neprilysin inhibitor, which promotes sodium excretion and has vasodilatory effects via relaxing blood vessels, Dapagliflozin reduce cardiac preload and afterload by inducing natriuresis and reducing arterial stiffness. Effects on blood pressure reduction and weight loss may also positively affect left ventricular (LV) remodelling. Using echocardiography, researchers hope to test the hypothesis that dapagliflozin improves MR in patients with functional MR due to LV dysfunction. This hypothesis is based on studies showing the beneficial effects of Dapagliflozin on LV modelling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin Farxiga®
Other Intervention Name(s)
Forxiga
Intervention Description
Dapagliflozin 10 mg once daily
Intervention Type
Drug
Intervention Name(s)
Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®
Other Intervention Name(s)
Tritace, Carvid, Aldactone
Intervention Description
Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily
Primary Outcome Measure Information:
Title
Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures
Description
Change in median / mean of EROA before and after drug administration
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients
Description
Change in median / mean of ProBNP before and after drug administration
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients ≥ 18 years of age Dilated LV with a reduced ejection fraction and secondary functional MR NYHA functional class II or III Moderate to Severe MR which lasted > 6 months under medical treatment with a β-blocker and an ACE inhibitor (or ARB) Exclusion Criteria: Current use or prior use of Dapagliflozin Current acute heart failure or prior admission with acute decompensated heart failure in 6 months before entry to study NYHA functional class IV Chronic renal impairment with GFR < 30 mL/min/1.73m2 Pregnant or lactating women History of allergy to Dapagliflozin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Essam Abou Warda, MSc
Phone
+201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Mohamed Sarhan, Phd
Phone
01008789509
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Essam Abou Warda
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-suef University
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed E Abou Warda, MSc
Phone
00201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name & Degree
Rania Sarhan, Ph.D
First Name & Middle Initial & Last Name & Degree
Mohamed Nabil, MD
First Name & Middle Initial & Last Name & Degree
Bassem Zarif, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Dapagliflozin on Secondary Mitral Regurgitation

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