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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin 10 mg | Experimental | In this group the patients will receive the medication empagliflozin 10 mg |
|
| Empagliflozin 25 mg | Experimental | In this group the patients will receive the medication empagliflozin 25 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life - application of Kansas City Cardiomyopathy Questionnaire | Applying the Kansas City Cardiomyopathy Questionnaire (KCCQ TSS) at inclusion and 60 days post-intervention in the two groups. | At inclusion and 60 days after receiving the medication. |
| Quality of Life - Difference in the 6-minute walk test | Evaluate the difference in the 6-minute walk test before and after receiving the medication | At inclusion and 60 days after receiving the medication. |
| Ejection fraction | 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). | Before receiving the drug and 60 days after. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conrado R Hoffmann Filho, Doctor | Multidisciplinary Center for Specialized Education and Research Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multidisciplinary Center for Specialized Education and Research Ltd. | Joinville | Santa Catarina | 89204250 | Brazil |
Due to current Brazilian data protection law all individual participant data must be kept in secrecy.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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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.
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