Health Condition 1: null- Ventricular septal defect with heart failure
Conditions
Interventions
Intervention1: Propranolol: Propranolol will be started at a dose of 1 mg/kg/day in divided doses and will be escalated at weekly interval to 2 mg/kg/day or as maximum as tolerated to achieve a mean h
Sponsors
Individual
Eligibility
Inclusion criteria
Inclusion criteria: Infants 2 to 6-months of age with features of heart failure with a large to moderate VSD who are not otherwise candidates for immediate surgery
Exclusion criteria
Exclusion criteria: 1. Asymptomatic patient 2. Patient in whom closure of VSD is indicated at the present moment (as per proposed Indian Guidelines) a. Significant pulmonary artery hypertension b. Uncontrolled CHF c. Significant failure to thrive d. Hospitalization for pneumonia/CHF 3. Associated congenital cardiac defects that are likely require intervention including coarctation of aorta, patent ductus arteriosus 4. Down?s syndrome and other syndromic disorders with VSD 5. Major associated anomalies predisposing to chest infection like TEF 6. Severe anemia (Hb < 9 gm%) 7. Renal or hepatic dysfunction 8. Hypersensitivity or contraindication to use of propranolol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite end point of death, hospitalization for heart failure and/or chest infection, or referral for VSD closure surgeryTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All components of primary endpoint individually 2. Chest infection 3. Ross Heart failure score 4. Ross functional class 5. Weight gain & Failure to thrive 6. Brain natriuretic peptide levels Timepoint: 3, 6, 12 months | — |
Countries
India
Contacts
Public ContactS Ramakrishnan
AIIMS, New delhi
Outcome results
None listed