Clinical trial NCT06683053: Evaluation of the Use of Empagliflozin in Patients with HF with PEF in a Cardiology Outpatient Department
Official title: Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Congestive Heart Failure (CHF)
Keywords: congestive heart failure
preserved ejection fraction
empagliflozin
Lead sponsor: Multidisciplinary Center for Specialized Education and Research Ltd.
Sponsor class: NETWORK
First posted: 2024-11-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind, randomized study comparing the efficacy and safety of empagliflozin at doses of 10 and 25 mg in patients with HFpEF. The Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) will be applied at inclusion and 8 weeks post-intervention in the two groups. And the use of echocardiogram performed upon entering the study, with assessment of ventricular and atrial strain modalities, and being repeated at the end of the treatment period to try to detect possible differences between pre and post treatment with the proposed ISGLT2.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life - application of Kansas City Cardiomyopathy Questionnaire
timeFrame: At inclusion and 60 days after receiving the medication.
measure: Quality of Life - Difference in the 6-minute walk test
timeFrame: At inclusion and 60 days after receiving the medication.
measure: Ejection fraction
timeFrame: Before receiving the drug and 60 days after.
Secondary outcomes:
Other outcomes:
Locations:
city: Joinville
country: Brazil
facility: Multidisciplinary Center for Specialized Education and Research Ltd.
state: Santa Catarina
Study officials:
affiliation: Multidisciplinary Center for Specialized Education and Research Ltd.
name: Conrado R Hoffmann Filho, Doctor
role: PRINCIPAL_INVESTIGATOR
References: