Clinical trial NCT05828524: Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity
Official title: Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Pulmonary Valve Stenoses
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population with an age more than or equal to 16 years of age at time of procedure

Brief 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

Eligibility criteria: Inclusion Criteria:

* 1-Adult population with an age more than or equal to 16 years of age at time of procedure 2-Severe valvular Pulmonary stenosis defined as a PG max more than or equal to 64 mmHg measured by 2d echo before Procedure

Exclusion Criteria:

1. Patients with isolated supra-valvular and sub valvular pulmonary stenosis
2. Patients with peripheral pulmonary stenosis.
3. Patients with pulmonary stenosis if part of another congenital heart disease .
4. Patients with organically diseased Tricuspid valve
5. Patients with any significant shunt lesion which result in dilation in RV such as atrial septal defect.
6. Patients with right ventricular dysfunction due to arrhythmogenic right ventricular dysplasia (ARVD) or non compaction

Primary outcomes:
measure: reverse Right ventricular remodeling
timeFrame: one year
measure: functional exercise capacity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine Assiut university
Study officials:
References:
citation: Gozar L, Iancu M, Gozar H, Sglimbea A, Cerghit Paler A, Gabor-Miklosi D, Toganel R, Fagarasan A, Iurian DR, Toma D. Assessment of Biventricular Myocardial Function with 2-Dimensional Strain and Conventional Echocardiographic Parameters: A Comparative Analysis in Healthy Infants and Patients with Severe and Critical Pulmonary Stenosis. J Pers Med. 2022 Jan 6;12(1):57. doi: 10.3390/jpm12010057.
citation: Mansour A, Elfiky AA, Mohamed AS, Ezzeldin DA. Mechanism of the right ventricular reverse remodeling after balloon pulmonary valvuloplasty in patients with congenital pulmonary stenosis: A three-dimensional echocardiographic study. Ann Pediatr Cardiol. 2020 Apr-Jun;13(2):123-129. doi: 10.4103/apc.APC_93_18. Epub 2020 Mar 20.
citation: Deng RD, Zhang FW, Zhao GZ, Wen B, Wang SZ, Ou-Yang WB, Liu Y, Xie YQ, Pan XB. A novel double-balloon catheter for percutaneous balloon pulmonary valvuloplasty under echocardiographic guidance only. J Cardiol. 2020 Sep;76(3):236-243. doi: 10.1016/j.jjcc.2020.03.014. Epub 2020 May 22.
citation: Behjati-Ardakani M, Forouzannia SK, Abdollahi MH, Sarebanhassanabadi M. Immediate, short, intermediate and long-term results of balloon valvuloplasty in congenital pulmonary valve stenosis. Acta Med Iran. 2013 May 30;51(5):324-8.
citation: Alyan O, Ozdemir O, Kacmaz F, Topaloglu S, Ozbakir C, Gozu A, Korkmaz S, Toprak N. Sympathetic overactivity in patients with pulmonary stenosis and improvement after percutaneous balloon valvuloplasty. Ann Noninvasive Electrocardiol. 2008 Jul;13(3):257-65. doi: 10.1111/j.1542-474X.2008.00229.x.