Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Phase 4

Recruiting

• Conditions: Dapagliflozin Adverse Reaction; Efficacy; Systemic Right Ventricle
• Interventions: Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT05717257
• Lead Sponsor: Monaldi Hospital

Brief 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.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age≥18years
• Optimal medical therapy or at least 3months
• Systemic right ventricle ejection fraction≤40%, assessed on echocardiography

Exclusion Criteria

• Univentricular physiology
• Systolic blood pressure<90mmHg
• Glomerular filtration rate(GFR)<30ml/min

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Systemic right ventricle global longitudinal strain	1 year
Systemic right ventricle fractional area change	1 year
Adverse Events	1 year	Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Nt-proBNP	1 year

Trial Locations

Locations (1)

Adult Congenital Heart Disease, Monaldi Hospital; 🇮🇹 Naples, Italy