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

Sponsor
October 6 University
Study ID
NCT05849766
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin Farxiga® — DRUG
    Dapagliflozin 10 mg once daily
  • Ramipril Tritace®, Carvedilol Carvid®,and Spironolactone Aldactone® — DRUG
    Ramipril 10 mg once daily, carvedilol 6.25 mg twice daily and spironolactone 25 once daily

Study Details

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.

Key Dates

Start date
Apr 27, 2023
Status verified
Oct 2024
Primary completion
May 1, 2024
Completion
Sep 1, 2024

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Control
    Group 1 received only standard therapy ACE/ ARB, BB, and diuretics
  • Experimental: Interventional
    Group 2 received dapagliflozin 10 mg once daily in addition to standard therapy ACE/ ARB, BB, and diuretics

Primary Outcome Measure

Median / Mean of effective regurgitant orifice area (EROA) of functional mitral regurgitation in patient echocardiographic measures [ Time Frame: 6 months ]

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