ARNI Combined With SGLT2 Inhibitors on Functional Mitral Regurgitation Remodeling

Sponsor
Rehab Werida
Study ID
NCT07379788
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Sacubitril/Valsartan 49 MG-51 MG Oral Tablet [ENTRESTO] — DRUG
    Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet without concomitant SGLT2 inhibitor therapy.
  • Empagliflozin10Mg Tab — DRUG
    Combination Therapy Group: Patients receiving Sacubitril/Valsartan 49 MG-51 MG Oral Tablet in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).

Study Details

This study aimed to compare the effects of ARNI monotherapy versus combined ARNI and SGLT2 inhibitor therapy on Mitral Remodeling Index (MRIx) and Functional mitral regurgitation (FMR) remodeling in patients with heart failure with reduced ejection fraction (HFrEF).

Key Dates

Start date
Jan 1, 2025
Status verified
May 2026
Primary completion
Feb 28, 2026
Completion
Mar 1, 2026

Study Design

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

Arms

  • Placebo Comparator: ARNI Monotherapy Group:
    Patients receiving sacubitril/valsartan without concomitant SGLT2 inhibitor therapy.
  • Active Comparator: Combination Therapy Group:
    Patients receiving sacubitril/valsartan in combination with an SGLT2 inhibitor (empagliflozin 10 mg daily).

Primary Outcome Measure

LVEF % [ Time Frame: 6 months ]

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