heart failure with left ventricular ejection fraction <50% MedDRA version: 20.0 Level: LLT Classification code 10024102 Term: Left cardiac failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: FORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 28 COMPRESSE
Product Name: Dapagliflozin
Product Code: [Dapagliflozin]
Pharmaceutical Form: F
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients can be included in the study only if they meet the following criteria: 1. Providing informed consent prior to any specific study procedure 2. Female or male non-diabetic outpatients> 18 years 3. Have heart failure with left ventricular ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: Patients cannot be included in the study if only one of the following exclusion criteria is present: 1. Involvement in study planning and / or conducting (applies to both investigator staff and study site staff) 2. Previous enrollment or randomization in the present study 3. Participation in another clinical study with an investigational product within the past 6 months 4. Previous treatment with any SGLT2 inhibitor 5. Type II diabetes mellitus 6. Atrial fibrillation at the time of enrollment 7. Chronic kidney damage with creatinine clearance CTCAE grade 2) caused by previous anticancer therapies, excluding alopecia 14. Patients on dialysis 15. Patients with known hypersensitivity to Dapagliflozin or to any of the excipients of the product 16. Any concomitant drug known to be associated with Torsades de pointes or potent inducers of cytochrome P450 3A4 (CYP3A4) 17. History of QT prolongation associated with other drugs that required discontinuation of that drug 18. Congenital long QT syndrome 19. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: determine the changes over time in left ventricular myocardial performance in non-diabetic patients with HFrEF and HFmrEF treated with Dapagliflozin at 3 and 6 months of follow up, compared to the standard of care of optimal medical therapy according to the ESC guidelines for heart failure.;Secondary Objective: Evaluate the effect of Dapagliflozin in addition to optimal medical therapy after 3 and 6 months of treatment against the standard of care regarding: - reverse remodeling of the left ventricle - left ventricular diastolic function and congestion. - structure and function of the right ventricle - cardiovascular clinical events (hospitalization for heart failure, cardiovascular death and death from all causes). Exploratory Objectives: To evaluate the effects of Dapagliflozin in addition to optimal medical therapy on the burden of heart failure symptoms relative to standard of care.;Primary end point(s): Determine changes over time (at 3 and 6 months) in left ventricular myocardial performance by basal and speckle tracking echocardiography in non-diabetic patients with HFrEF and HFmrEF treated with Dapagliflozin in addition to optimal medical therapy, compared to standard of care according to ESC guidelines for heart failure .;Timepoint(s) of evaluation of this end point: at 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the effect of Dapagliflozin in addition to optimal medical therapy after 3 and 6 months of treatment against the standard of care regarding: - reverse remodeling of the left ventricle - left ventricular diastolic function and congestion. - structure and function of the right ventricle - cardiovascular clinical events (hospitalization for heart failure, cardiovascular death and death from all causes).;Timepoint(s) of evaluation of this end point: after 3 and 6 months | — |
Countries
Italy
Contacts
Public ContactU.O.C. Diagnostica Cardiovascolare
AZIENDA OSPEDALIERO UNIVERSITARIA SENESE
Outcome results
None listed