NCT06683053

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

Evaluation of the Use of Empagliflozin in Patients with Heart Failure with Preserved Ejection Fraction in a Cardiology Outpatient Department

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Conrado Roberto Hoffmann Filho · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congestive Heart Failure (CHF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-17
• Primary completion: 2024-04-29
• Completion: 2025-02-28
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: Brazil