NCT04960085

Brief Summary

Correct assessment of right ventricular function by transthoracic echocardiographic examination in pediatric patients with congenital valvular pulmonary stenosis after Percutaneous Balloon Pulmonary Valvuloplasty

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

July 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2022

Completed
Last Updated

July 13, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 2, 2021

Last Update Submit

July 2, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • correlation between right ventricular dysfunction and severity of valvular pulmonary stenosis

    tissue Doppler of the right ventricle before and after trans cutaneous pulmonary valvuloplasty

    baseline

Interventions

philips IE33

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients with valvular pulmonary stenosis who will undergo trans cutaneous pulmonary valvuloplasty

You may qualify if:

  • All pediatric patients with congenital valvular pulmonary stenosis attending echocardiographic outpatient clinic of Assuit University children hospital aged from one month to18 years old

You may not qualify if:

  • Age less than one month and older than 18 years. Patients with infundibular and supravalvular pulmonary stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Pierpont ME, Basson CT, Benson DW Jr, Gelb BD, Giglia TM, Goldmuntz E, McGee G, Sable CA, Srivastava D, Webb CL; American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young. Genetic basis for congenital heart defects: current knowledge: a scientific statement from the American Heart Association Congenital Cardiac Defects Committee, Council on Cardiovascular Disease in the Young: endorsed by the American Academy of Pediatrics. Circulation. 2007 Jun 12;115(23):3015-38. doi: 10.1161/CIRCULATIONAHA.106.183056. Epub 2007 May 22.

    PMID: 17519398BACKGROUND
  • Baumgartner H, Bonhoeffer P, De Groot NM, de Haan F, Deanfield JE, Galie N, Gatzoulis MA, Gohlke-Baerwolf C, Kaemmerer H, Kilner P, Meijboom F, Mulder BJ, Oechslin E, Oliver JM, Serraf A, Szatmari A, Thaulow E, Vouhe PR, Walma E; Task Force on the Management of Grown-up Congenital Heart Disease of the European Society of Cardiology (ESC); Association for European Paediatric Cardiology (AEPC); ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010 Dec;31(23):2915-57. doi: 10.1093/eurheartj/ehq249. Epub 2010 Aug 27. No abstract available.

    PMID: 20801927BACKGROUND
  • Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.

    PMID: 18378625BACKGROUND
  • Haddad F, Hunt SA, Rosenthal DN, Murphy DJ. Right ventricular function in cardiovascular disease, part I: Anatomy, physiology, aging, and functional assessment of the right ventricle. Circulation. 2008 Mar 18;117(11):1436-48. doi: 10.1161/CIRCULATIONAHA.107.653576. No abstract available.

    PMID: 18347220BACKGROUND
  • Hornung TS, Bernard EJ, Jaeggi ET, Howman-Giles RB, Celermajer DS, Hawker RE. Myocardial perfusion defects and associated systemic ventricular dysfunction in congenitally corrected transposition of the great arteries. Heart. 1998 Oct;80(4):322-6. doi: 10.1136/hrt.80.4.322.

    PMID: 9875104BACKGROUND
  • Hauser M, Bengel FM, Hager A, Kuehn A, Nekolla SG, Kaemmerer H, Schwaiger M, Hess J. Impaired myocardial blood flow and coronary flow reserve of the anatomical right systemic ventricle in patients with congenitally corrected transposition of the great arteries. Heart. 2003 Oct;89(10):1231-5. doi: 10.1136/heart.89.10.1231.

    PMID: 12975428BACKGROUND
  • Davlouros PA, Niwa K, Webb G, Gatzoulis MA. The right ventricle in congenital heart disease. Heart. 2006 Apr;92 Suppl 1(Suppl 1):i27-38. doi: 10.1136/hrt.2005.077438.

    PMID: 16543599BACKGROUND
  • Cheung MM, Smallhorn JF, Redington AN, Vogel M. The effects of changes in loading conditions and modulation of inotropic state on the myocardial performance index: comparison with conductance catheter measurements. Eur Heart J. 2004 Dec;25(24):2238-42. doi: 10.1016/j.ehj.2004.07.034.

    PMID: 15589642BACKGROUND
  • Vogel M, Sponring J, Cullen S, Deanfield JE, Redington AN. Regional wall motion and abnormalities of electrical depolarization and repolarization in patients after surgical repair of tetralogy of Fallot. Circulation. 2001 Mar 27;103(12):1669-73. doi: 10.1161/01.cir.103.12.1669.

    PMID: 11273995BACKGROUND
  • Vogel M, Schmidt MR, Kristiansen SB, Cheung M, White PA, Sorensen K, Redington AN. Validation of myocardial acceleration during isovolumic contraction as a novel noninvasive index of right ventricular contractility: comparison with ventricular pressure-volume relations in an animal model. Circulation. 2002 Apr 9;105(14):1693-9. doi: 10.1161/01.cir.0000013773.67850.ba.

    PMID: 11940549BACKGROUND
  • Vogel M, Derrick G, White PA, Cullen S, Aichner H, Deanfield J, Redington AN. Systemic ventricular function in patients with transposition of the great arteries after atrial repair: a tissue Doppler and conductance catheter study. J Am Coll Cardiol. 2004 Jan 7;43(1):100-6. doi: 10.1016/j.jacc.2003.06.018.

    PMID: 14715190BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Saad Abdelhafiz Abdelsalam, master degree

CONTACT

Nagwa Ali Mohamed, prof (MD)

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Egypt, Assuit

Study Record Dates

First Submitted

July 2, 2021

First Posted

July 13, 2021

Study Start

July 2, 2021

Primary Completion

July 2, 2022

Study Completion

August 2, 2022

Last Updated

July 13, 2021

Record last verified: 2021-07