A clinical trial to study the effects of propranolol (a beta blocking drug) in children with ventricular septal defect and heart failure
- Conditions
- Health Condition 1: null- Ventricular septal defect with heart failure
- Registration Number
- CTRI/2009/091/000525
- Lead Sponsor
- Individual
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite end point of death, hospitalization for heart failure and/or chest infection, or referral for VSD closure surgeryTimepoint: 12 months
- Secondary Outcome Measures
Name Time Method 1.All components of primary endpoint individually<br>2.Chest infection<br>3.Ross Heart failure score<br>4.Ross functional class<br>5.Weight gain & Failure to thrive<br>6.Brain natriuretic peptide levels<br>Timepoint: 3, 6, 12 months