A clinical trial to study the effect of a drug, Sildenafil, increase bloodflow in the lungs and prevent damage to the heart in children during operations to close connections between the two heart-halves.
Phase 4
- Conditions
- Health Condition 1: null- Ventricle Septum Defect (closure)Ischemia-reperfusion cardiac damage.Pulmonary Hypertension
- Registration Number
- CTRI/2014/03/004468
- Lead Sponsor
- The Department of Physiology at Maastricht University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Children with ventricular septal defect (VSD) with pure L-R shunt (moderate pulmonary hypertension) undergoing surgical closure of the VSD.
-Sex: Male and Female.
-Age: < 8 years.
-Isolated VSD without associated lesions.
Exclusion Criteria
-Critical illness
-Circulatory insufficiency
-Pre-existent atrioventricular block (AV-block)
-Bleeding disorders
--Estimated need for postoperative use of Sildenafil for severe pulmonary hypertension (VSD with severe PAH)
-VSD with no PAH
-Ventriculotomy approach
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method