Dapagliflozin Adverse Reaction, Efficacy, Systemic Right Ventricle
Conditions
Keywords
heart failure, dapagliflozin, systemic right ventricle
Brief summary
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
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.
Interventions
DRUGDapagliflozin 10mg Tab
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Sponsors
Monaldi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to the treatment or control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | Absence of any suspected or confirmed adverse events or necessity of drug discontinuation |
| Nt-proBNP | 1 year | — |
| Systemic right ventricle fractional area change | 1 year | — |
| Systemic right ventricle global longitudinal strain | 1 year | — |
Countries
Italy
Outcome results
None listed