Effect of Dapagliflozin on Cardiac Structure, Function and Secondary Mitral Regurgitation in Patients with Left Ventricle Dysfunction

NCT05849766 | Completed Phase 3

• 1 other identifier: IHC00044
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (2)

• Median / Mean of Left ventricle Ejection Fraction (LVEF) of patients in patient echocardiographic measures

  6 months

• Median / Mean of Natriuretic peptide concentration (ProBNP) in serum of patients

  6 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone®

Interventional

EXPERIMENTAL

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

Drug: Dapagliflozin Farxiga®

Interventions

Dapagliflozin Farxiga® DRUG

Dapagliflozin 10 mg once daily

Also known as: Forxiga

Interventional

Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® DRUG

Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily

Also known as: Tritace, Carvid, Aldactone

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead
• National Heart Institute, Egypt: collaborator
• University of Florida: collaborator

Study Sites (1)

Beni-suef University

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

dapagliflozin; Ramipril; Spironolactone

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ahmed Essam Abou Warda

  October 6 University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 9, 2023
• Study Start: April 27, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)