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

Last updated: November 8, 2024
Sponsor: Conrado Roberto Hoffmann Filho
Overall Status: Active - Not Recruiting

Phase

3

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

empagliflozin

Clinical Study ID

NCT06683053
CMEP
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients >18 years old.

  • Echocardiogram with ejection fraction > 50%

  • Patients must present at least one of the following items to be included in thestudy: Patients with a previous diagnosis of Heart Failure with Reduced EjectionFraction (HFrEF) who have improved on the echocardiogram to an ejection fractionabove 50%, patients with a previous ejection fraction between 40-49% who haveprogressed to ejection fraction above 50%. For these groups there is no need toperform the score for heart failure with preserved ejetion fraction score (since thediagnosis of HF was already known). Patients with signs/symptoms of HFpEF, whopresent structural morphological changes such as left atrium enlargement or leftventricular hypertrophy (LVH).

  • After recently undergoing the score for heart failure with preserved ejetionfraction score (H2FPEF), patients who present scores that place them at least at anintermediate probability of HFpEF would be eligible for entry into the study.

  • Signing the consent form

Exclusion

Exclusion Criteria:

  • Patient with type I DM

  • Estimated glomerular filtration rate (eGFR), using the Chronic Kidney DiseaseEpidemiology (CKD EPI) equation, with a cutoff of <20 mL/mm/1.73m2

  • Patient currently using SGLT2 antagonists

  • Patient with a history of allergic reaction or significant sensitivity toempagliflozin

  • Female patient who is pregnant or considering becoming pregnant during the study orfor 3 months after the last dose of study medication

  • Patients that are breastfeeding

  • Patients considered by the investigator, for any reason, to be an unsuitablecandidate for the study

  • Patients with a previous diagnosis of HFpEF who presents a low probability ofdiagnosis after being re-stratified by the previously mentioned score

  • Patients unable to walk or understand/comply with the study protocol.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: empagliflozin
Phase: 3
Study Start date:
March 17, 2023
Estimated Completion Date:
February 28, 2025

Study Description

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. Patients will be randomized and will receive one of the two doses of empagliflozin. All patients in both groups will be equally evaluated by the tests, before receiving the medication, and also 8 weeks after.

Connect with a study center

  • Multidisciplinary Center for Specialized Education and Research Ltd.

    Joinville, Santa Catarina 89204250
    Brazil

    Site Not Available

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