A Phase 3 interventional study of empagliflozin in Congestive Heart Failure (CHF), sponsored by Conrado Roberto Hoffmann Filho. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Conrado Roberto Hoffmann Filho · Phase 3, Interventional, and Treatment
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 90 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Conrado Roberto Hoffmann Filho as lead sponsor.
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Exclusion Criteria:
In this group the patients will receive the medication empagliflozin 10 mg
Drug: empagliflozin
In this group the patients will receive the medication empagliflozin 25 mg.
Drug: empagliflozin
Comparing the benefits of both doses of empagliflozin (10 mg versus 25 mg) in terms of heart ejection fraction and quality of life.
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.
Time frame: 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
Time frame: 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).
Time frame: Before receiving the drug and 60 days after.
Plan to share: No — Due to current Brazilian data protection law all individual participant data must be kept in secrecy.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin