Congenital Heart DiseaseNCT05828524
Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity
An observational study of Congenital Heart Disease and Pulmonary Valve Stenoses, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Heart Disease, Pulmonary Valve Stenoses
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Adult population with an age more than or equal to 16 years of age at time of procedure
Who may be able to join
- 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
Who cannot join
- Patients with isolated supra-valvular and sub valvular pulmonary stenosis
- Patients with peripheral pulmonary stenosis.
- Patients with pulmonary stenosis if part of another congenital heart disease .
- Patients with organically diseased Tricuspid valve
- Patients with any significant shunt lesion which result in dilation in RV such as atrial septal defect.
- Patients with right ventricular dysfunction due to arrhythmogenic right ventricular dysplasia (ARVD) or non compaction
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Assiut university
Asyut, 71515
salah eldin Abbas, +201550541009, salaheldin017@gmail.com
Noha Gamal, professor, +2001002295166, nohagamal86@gmail.com
About this study
Official title: Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity
A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to
- - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
- - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
Read the 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
- - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
- - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
- Conditions
- Congenital Heart Disease, Pulmonary Valve Stenoses
- Medical subject headings
- Heart Defects, Congenital, Pulmonary Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
reverse Right ventricular remodeling
reverse right ventricular remodeling detected by cardiac MRI and 2D echocardiography after
Measured: one year
functional exercise capacity
assessment of functional exercise capacity by performing six minutes walk test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start10 Jan 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Eldin Mohammed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828524
- Sponsor's protocol ID
- BPVP
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35055372Mansour 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.
PubMed 32641883Deng 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.
PubMed 32451153Behjati-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.
PubMed 23737317Alyan 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.
PubMed 18713326
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodeling and Functional Exercise Capacity
- ClinicalTrials.gov ID
- NCT05828524
- Acronym / sponsor ID
- BPVP
- Conditions
- Congenital Heart Disease, Pulmonary Valve Stenoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to
- - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
- - 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
- - evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation
- - evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Adult population with an age more than or equal to 16 years of age at time of procedure
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with isolated supra-valvular and sub valvular pulmonary stenosis
- Patients with peripheral pulmonary stenosis.
- Patients with pulmonary stenosis if part of another congenital heart disease .
- Patients with organically diseased Tricuspid valve
- Patients with any significant shunt lesion which result in dilation in RV such as atrial septal defect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reverse Right ventricular remodeling
Time frame: one year
reverse right ventricular remodeling detected by cardiac MRI and 2D echocardiography after
functional exercise capacity
Time frame: one year
assessment of functional exercise capacity by performing six minutes walk test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 35055372Gozar 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.
- Background: PubMed 32641883Mansour 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.
- Background: PubMed 32451153Deng 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.
- Background: PubMed 23737317Behjati-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.
- Background: PubMed 18713326Alyan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pulmonary Valve Stenoses, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reverse Right ventricular remodeling (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828524, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.