Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department

Sponsor
Conrado Roberto Hoffmann Filho
Study ID
NCT06683053
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Congestive Heart Failure (CHF)

Eligibility Criteria

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

Interventions

  • empagliflozin — DRUG
    Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.

Study Details

This study aims to evaluate whether the use of a 25 mg dose of empagliflozin compared to the 10 mg dose used would bring additional benefits in the improvement outcomes of the Kansas City Cardiomyopathy Questionnaire (KCCQ SST), in the 6-minute walk test (6MWT) without causing significant side effects.

Key Dates

Start date
Mar 17, 2023
Status verified
Nov 2024
Primary completion
Apr 29, 2024
Completion
Feb 28, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin 10 mg
    In this group the patients will receive the medication empagliflozin 10 mg
  • Experimental: Empagliflozin 25 mg
    In this group the patients will receive the medication empagliflozin 25 mg.

Primary Outcome Measure

Quality of life - application of Kansas City Cardiomyopathy Questionnaire [ Time Frame: At inclusion and 60 days after receiving the medication. ]

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