Congestive Heart Failure (CHF)
Conditions
Keywords
congestive heart failure, preserved ejection fraction, empagliflozin
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.
Interventions
DRUGempagliflozin
Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.
Sponsors
Conrado Roberto Hoffmann Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - application of Kansas City Cardiomyopathy Questionnaire | At inclusion and 60 days after receiving the medication. | Applying the Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) at inclusion and 60 days post-intervention in the two groups. |
| Quality of Life - Difference in the 6-minute walk test | At inclusion and 60 days after receiving the medication. | Evaluate the difference in the 6-minute walk test before and after receiving the medication |
| Ejection fraction | Before receiving the drug and 60 days after. | Using the echocardiogram upon entering the study, with assessment of ventricular and atrial strain modalities, repeating the same at the end of the treatment period to try to detect possible differences between pre and post treatment with the proposed Sodium-Glucose Transporter 2 Inhibitors (ISGLT2). |
Countries
Brazil
Outcome results
None listed