Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Monaldi Hospital

Status and phase: Enrolling; Phase 4

Conditions: Dapagliflozin Adverse Reaction; Systemic Right Ventricle; Efficacy

Treatments: Drug: Dapagliflozin 10mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05717257

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction

Treatment:

Drug: Dapagliflozin 10mg Tab

Control

No Intervention group

Description:

Participants assigned to this group will continue the standard optimized medical therapy