Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere
Conditions
Interventions
Intervention1: Sirolimus administration to children with cardiac rhabdomyoma: Eligible participants will be randomized into two groups: an intervention arm, which will receive sirolimus at an initial
Sponsors
Department of Cardiology, All India Institute Of Medical Sciences, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Children younger than 12 years with cardiac rhabdomyoma
Exclusion criteria
Exclusion criteria: 1.Symptomatic patients with either of the following: Heart failure, Intractable arrhythmias, Moderate to severe LV systolic dysfunction, Moderate to severe LV outflow tract obstruction, Moderate to severe RV outflow tract obstruction 2.Largest residual rhabdomyoma measuring less than 5 mm 3.Inability to take oral medications. Contraindications to sirolimus Active infection Allergy to sirolimus Hemoglobin less than 9g/dL Platelets less than 80000/mm3 Absolute neutrophil count less than 1000/mm3 Fasting serum cholesterol more than 200 mg/dL Fasting serum triglycerides more than 200 mg/dL Hepatic derangement Renal dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of children having more than 50% reduction in the size of the largest cardiac rhabdomyoma at 3 months follow upTimepoint: At 1 month, 2 month and 3 month follow up after administrating sirolimus. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the rate of regression of cardiac rhabdomyoma with or without oral sirolimus therapyTimepoint: At 1 month, 2 month and 3 month follow up after administrating sirolimus.;2. To evaluate the safety and tolerability of sirolimus in children with cardiac rhabdomyomaTimepoint: At 1 month, 2 month and 3 month follow up after administrating sirolimus. | — |
Countries
India
Contacts
Public ContactSaurabh Kumar Gupta
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed