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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction |
|
| Control | No Intervention | Participants assigned to this group will continue the standard optimized medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adult Congenital Heart Disease, Monaldi Hospital | Recruiting | Naples | 80121 | Italy |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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Participants will be randomly assigned to the treatment or control group
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