Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dapagliflozin Adverse Reaction, Efficacy, Systemic Right Ventricle

Intervention / Treatment
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* Drug: Dapagliflozin 10mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to the treatment or control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin<br>Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction | Drug: Dapagliflozin 10mg Tab<br>* Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction<br>|
| No Intervention: Control<br>Participants assigned to this group will continue the standard optimized medical therapy | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart failure, dapagliflozin, systemic right ventricle