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

Conrado Roberto Hoffmann Filho

Status and phase

Active, not recruiting

Phase 3

Conditions

Congestive Heart Failure (CHF)

Treatments

Drug: empagliflozin

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06683053

CMEP

Details and patient eligibility

About

Full 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.

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 the study: Patients with a previous diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) who have improved on the echocardiogram to an ejection fraction above 50%, patients with a previous ejection fraction between 40-49% who have progressed to ejection fraction above 50%. For these groups there is no need to perform the score for heart failure with preserved ejetion fraction score (since the diagnosis of HF was already known). Patients with signs/symptoms of HFpEF, who present structural morphological changes such as left atrium enlargement or left ventricular hypertrophy (LVH).
After recently undergoing the score for heart failure with preserved ejetion fraction score (H2FPEF), patients who present scores that place them at least at an intermediate probability of HFpEF would be eligible for entry into the study.
Signing the consent form

Exclusion criteria

Patient with type I DM
Estimated glomerular filtration rate (eGFR), using the Chronic Kidney Disease Epidemiology (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 to empagliflozin
Female patient who is pregnant or considering becoming pregnant during the study or for 3 months after the last dose of study medication
Patients that are breastfeeding
Patients considered by the investigator, for any reason, to be an unsuitable candidate for the study
Patients with a previous diagnosis of HFpEF who presents a low probability of diagnosis after being re-stratified by the previously mentioned score
Patients unable to walk or understand/comply with the study protocol.