Health Condition 1: I420- Dilated cardiomyopathy
Conditions
Interventions
Intervention1: Dapagliflozin: Dosage (age wise)
1-1.5 year - 1.6mg
1.5 - 2 year - 2mg
2 - 6 year - 2.5mg
6-12 year - 5mg
Frequency - Once daily
Route of administration - Oral
Duration - 6 months
Con
Sponsors
Dr Nabeel Faisal V
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 1 year to 2. Chronic heart failure resulting from dilated cardiomyopathy and ventricular dysfunction receiving standard of care heart failure therapy 3. NYHA class II-IV (children 6 years to 4. LV ejection fraction 5. Etiologies of heart failure include: Idiopathic cardiomyopathy or history of myocarditis. 6. eGFR =30 ml/min/1.73 m2 (Shwartz formula) at enrolment
Exclusion criteria
Exclusion criteria: 1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor 2. Patient with type I diabetes mellitus 3. Patients with hemodynamically significant structural heart disease operated or unoperated 4. Patients with sustained or symptomatic dysrhythmias not controlled with drug or device therapy 5. HF due to restrictive cardiomyopathy, acute myocarditis (within 3 months of onset), constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, Familial or genetic cardiomyopathy, neuromuscular disease or uncorrected primary valvular disease 6. Symptomatic hypotension or BP below 5th percentile systolic BP for age at enrolment 7. Current acute decompensated HF or hospitalization due to decompensated HF 8. Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment 9. Severe (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of 1.First worsening heart failure; defined by signs and symptoms of worsening heart failure that requires intensification of HF therapy. 2.First hospitalization for HF 3.CV death Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| BNPTimepoint: 6 months;To study the incidence of adverse events • Serious adverse events • Discontinuation due to adverse event • Adverse events of interest o Volume depletion, renal events o Electrolyte abnormalities o Major hypoglycaemic events o DKA o Arrhythmias Timepoint: 6 months;Change in NYHA/ROSS HF class from enrolment to 6 months of therapyTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Nabeel Faisal V
All india institute of medical sciences
Outcome results
None listed