Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT07191093
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of RV Dysfunction After BPV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-21', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-09-21', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak transvalvular gradient after PBV', 'timeFrame': 'Baseline, 72 hours post-procedure, and 6 months follow-up.'}, {'measure': 'Change in mean transvalvular gradient after pulmonary balloon valvuloplasty', 'timeFrame': 'Baseline, 72 hours post-procedure, and 6 months follow-up.'}, {'measure': 'Change in estimated pulmonary artery systolic pressure PASP after PBV', 'timeFrame': 'Baseline, 72 hours post-procedure, and 6 months follow-up.'}, {'measure': 'Change in TAPSE after PBV', 'timeFrame': 'Baseline, 72 hours post-procedure, and 12 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Procedural outcomes and complications', 'timeFrame': 'one year', 'description': 'Acute procedural success (≥50% reduction in peak systolic gradient with final gradient \\<40 mmHg), development of pulmonary regurgitation (graded as mild, moderate, or severe), and occurrence of vascular or procedural complications (arrhythmias, balloon rupture, bleeding, etc.).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RV Dysfunction', 'Pulmonary Valvuloplasty']}, 'referencesModule': {'references': [{'pmid': '25559473', 'type': 'BACKGROUND', 'citation': 'Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.'}, {'pmid': '7099226', 'type': 'BACKGROUND', 'citation': 'Kan JS, White RI Jr, Mitchell SE, Gardner TJ. Percutaneous balloon valvuloplasty: a new method for treating congenital pulmonary-valve stenosis. N Engl J Med. 1982 Aug 26;307(9):540-2. doi: 10.1056/NEJM198208263070907. No abstract available.'}, {'pmid': '32860028', 'type': 'BACKGROUND', 'citation': 'Baumgartner H, De Backer J, Babu-Narayan SV, Budts W, Chessa M, Diller GP, Lung B, Kluin J, Lang IM, Meijboom F, Moons P, Mulder BJM, Oechslin E, Roos-Hesselink JW, Schwerzmann M, Sondergaard L, Zeppenfeld K; ESC Scientific Document Group. 2020 ESC Guidelines for the management of adult congenital heart disease. Eur Heart J. 2021 Feb 11;42(6):563-645. doi: 10.1093/eurheartj/ehaa554. No abstract available.'}, {'pmid': '30121239', 'type': 'BACKGROUND', 'citation': 'Stout KK, Daniels CJ, Aboulhosn JA, Bozkurt B, Broberg CS, Colman JM, Crumb SR, Dearani JA, Fuller S, Gurvitz M, Khairy P, Landzberg MJ, Saidi A, Valente AM, Van Hare GF. 2018 AHA/ACC Guideline for the Management of Adults With Congenital Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019 Apr 2;73(12):e81-e192. doi: 10.1016/j.jacc.2018.08.1029. Epub 2018 Aug 16. No abstract available.'}, {'pmid': '40419953', 'type': 'BACKGROUND', 'citation': 'Nasir M, Dejene K, Bedru M, Markos S. Percutaneous balloon pulmonary valvuloplasty in children: a 10-Year retrospective follow-up study in resource-limited settings. BMC Cardiovasc Disord. 2025 May 26;25(1):402. doi: 10.1186/s12872-025-04881-8.'}]}, 'descriptionModule': {'briefSummary': 'This aim focuses on :\n\nAssessing how common RV dysfunction is post-procedure Evaluating RV function changes over time (e.g., TAPSE, FAC, RV strain if available) Identifying risk factors or predictors (e.g., high residual gradient, severe PR, age at intervention)', 'detailedDescription': "Pulmonary stenosis (PS) is a congenital or acquired narrowing of the right ventricular outflow tract (RVOT) at the level of the pulmonary valve, leading to obstruction of blood flow from the right ventricle (RV) to the pulmonary artery. It accounts for approximately 8-10% of all congenital heart diseases and occurs most commonly as an isolated valvular lesion. Valvular PS is characterized by thickened, fused, or dysplastic pulmonary valve leaflets, resulting in increased right ventricular pressure and compensatory hypertrophy. Over time, if untreated, this can progress to right ventricular dilation, dysfunction, and right-sided heart failure.\n\nPulmonary balloon valvuloplasty (PBV) is the treatment of choice for moderate to severe valvular pulmonary stenosis. It is a minimally invasive, catheter-based intervention that involves dilation of the stenotic pulmonary valve using an appropriately sized balloon. The goal is to relieve obstruction, reduce right ventricular pressure, and prevent long-term complications such as RV hypertrophy, dysfunction, and arrhythmias. The procedure has shown excellent immediate and long-term outcomes, particularly in patients with a pliable, doming pulmonary valve and no significant regurgitation or associated congenital lesions.\n\nDespite the effectiveness and safety of PBV, complications can occur, and among them, right ventricular dysfunction is a critical concern. RV dysfunction post-valvuloplasty may result from several mechanisms, including longstanding pre-procedural pressure overload, myocardial fibrosis, sudden afterload reduction, procedural trauma, or development of significant pulmonary regurgitation. This dysfunction can be subtle or overt and may impact the long-term clinical outcome, exercise tolerance, and quality of life of patients.\n\nTherefore, understanding the predictors of right ventricular dysfunction after pulmonary balloon valvuloplasty is essential. Identifying high-risk patients pre-intervention and monitoring RV function post-procedure using echocardiographic parameters such as TAPSE, fractional area change (FAC), RV strain, and tricuspid annular tissue Doppler velocity (S') can guide better management strategies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include patients with isolated valvular pulmonary stenosis undergoing pulmonary balloon valvuloplasty (PBV) at the Cardiovascular Department, Assiut University Hospitals over 3 years. All ages will be included.\n\nExclusion criteria: patients with subvalvular/supravalvular PS, other major congenital heart disease, previous valve intervention, hemodynamic shock, or poor echo windows.\n\nA minimum of 60 patients will be recruited. Clinical data, ECG, echo (including speckle tracking), and procedural details will be collected. Patients will be followed at discharge, 1 month, and 6 months to assess RV function and outcomes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any age group(no age restriction) Diagnosis of isolated valvular pulmonary stenosis confirmed by echocardiographic evaluation.\n\nPatients who have undergone or are scheduled to undergo successful pulmonary balloon valvuloplasty (PBV), defined as a post-procedural peak gradient \\<40 mmHg with no significant residual obstruction.\n\nNormal or mildly dysplastic pulmonary valve morphology suitable for balloon valvuloplasty.\n\nNo history of prior cardiac surgery or transcatheter pulmonary valve intervention.\n\nExclusion Criteria:\n\n* Presence of other congenital heart diseases (e.g., TOF, VSD, ASD) Previous surgical or catheter-based intervention on the pulmonary valve. Dysplastic pulmonary valve morphology not suitable for PBV Subvalvular or supravalvular pulmonary stenosis. Development of significant procedural complications, such as severe pulmonary regurgitation requiring urgent surgical intervention.\n\nPatients in hemodynamic shock, with uncontrolled arrhythmias, or other unstable clinical conditions that may interfere with echocardiographic evaluation or follow-up.\n\nPresence of major systemic illnesses (e.g., advanced hepatic, renal, or pulmonary disease) that could independently affect right heart function or limit follow-up.'}, 'identificationModule': {'nctId': 'NCT07191093', 'briefTitle': 'Predictors of RV Dysfunction After BPV', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Predictors of Right Ventricle Dysfunction After Pulmonary Balloon Valvuloplasty', 'orgStudyIdInfo': {'id': 'RV Dysfunction post BPV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'pulmonary valvuloplasty', 'type': 'PROCEDURE', 'description': 'Pulmonary balloon valvuloplasty (PBV) is the treatment of choice for moderate to severe valvular pulmonary stenosis. It is a minimally invasive, catheter-based intervention that involves dilation of the stenotic pulmonary valve using an appropriately sized balloon. The goal is to relieve obstruction, reduce right ventricular pressure, and prevent long-term complications such as RV hypertrophy, dysfunction, and arrhythmias. The procedure has shown excellent immediate and long-term outcomes, particularly in patients with a pliable, doming pulmonary valve and no significant regurgitation or associated congenital lesions.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'salma mohamed taha, assistant professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Farah Fawzy', 'investigatorAffiliation': 'Assiut University'}}}}