Trials / Unknown
UnknownNCT05828524
Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity
Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Assiut University · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- —
Summary
A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to 1. \- evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation 2. \- evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
Detailed description
Valvular pulmonary stenosis (PS), defined as an obstruction of blood flow at the level of the pulmonary valve, is a form of congenital heart disease, described in 0.6-0.8 out of 1000 live births. The main physiologic effect of valvular pulmonary stenosis (PS) is an increase in Right ventricular pressure proportional to the severity of obstruction. This elevation of RV pressure is accompanied by an increase in muscle mass where hyperplasia of the muscle cells with a concomitant increase in the number of capillaries occurs. In contrast, the adult myocardium responds with hypertrophy of the existing fibers, with no change in the capillary network. Percutaneous balloon pulmonary valvuloplasty (PBPV) is the procedure of choice for uncomplicated severe or symptomatic pulmonary stenosis. the aim is to 1. \- evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation 2. \- evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
Conditions
Timeline
- Start date
- 2021-01-10
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-04-25
- Last updated
- 2023-04-25
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT05828524. Inclusion in this directory is not an endorsement.