Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity

Congenital Heart Disease Clinical Trial

Official title:

Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05828524
• Other study ID #: BPVP
• Status: Recruiting
• Start date: January 10, 2021
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Constriction, Pathologic
• Heart Defects, Congenital
• Heart Diseases
• Pulmonary Valve Stenosis
• Ventricular Remodeling

Locations

Country	Name	City	State
Egypt	Faculty of medicine Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reverse Right ventricular remodeling	reverse right ventricular remodeling detected by cardiac MRI and 2D echocardiography after	one year
Primary	functional exercise capacity	assessment of functional exercise capacity by performing six minutes walk test	one year