A Phase 4 interventional study of Dapagliflozin 10mg Tab in Dapagliflozin Adverse Reaction, Efficacy and Systemic Right Ventricle, sponsored by Monaldi Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Monaldi Hospital · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Drug: Dapagliflozin 10mg Tab
Participants assigned to this group will continue the standard optimized medical therapy
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Adverse Events
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Time frame: 1 year
Nt-proBNP
Time frame: 1 year
Systemic right ventricle fractional area change
Time frame: 1 year
Systemic right ventricle global longitudinal strain
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Monaldi Hospital