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Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Non Recruiting
18 years and older
All
Phase 4

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Overview

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.

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.

Eligibility

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 details
    Dapagliflozin Adverse Reaction
    Efficacy
    Systemic Right Ventricle

NCT05717257

Monaldi Hospital

20 August 2025

FAQs

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