Benefits of Empagliflozin in Patients With Heart Failure and Reduced Ejection Fraction Without Diabetes Mellitus

Sponsor
Ashraf Wasfy Beshay Aziz
Study ID
NCT06632561
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 mg — DRUG
    Empagliflozin (a sodium-glucose cotransporter-2 inhibitor) 10 mg one tablet daily dose for 6 months
  • Placebo — DRUG
    Sugar pills one tablet daily for 6 months

Study Details

The study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on LV end-diastolic and end-systolic volumes, LV ejection fraction, N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity and quality of life (QoL) among non-diabetic patients with HFrEF.

Key Dates

Start date
Jul 26, 2021
Status verified
Oct 2024
Primary completion
Mar 9, 2022
Completion
Mar 14, 2022

Study Design

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

Arms

  • Experimental: Empagliflozin arm
    37 patients received Empagliflozin 10 mg/day in addition to their guideline-directed medical therapy for HF
  • Placebo Comparator: Placebo arm
    37 patients received placebo in addition to their guideline-directed medical therapy for HF

Primary Outcome Measure

The changes in LV volumes (mL) [ Time Frame: From enrollment to the end of treatment at 6 months ]

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