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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Adult Congenital Heart Disease, Monaldi Hospital
Naples, Italy
RECRUITINGAdverse 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
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