NCT05717257

Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Monaldi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.

Detailed description

This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle. Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction. Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.

Conditions

• Dapagliflozin Adverse Reaction
• Efficacy
• Systemic Right Ventricle

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2023-02-08
• Last updated: 2023-02-08

Locations

1 site across 1 country: Italy