NCT05620992

Brief Summary

We aim to determine the function of Right ventricle post mitral valve surgeries in patients with pulmonary hypertension using transthoracic echocardiography3- and 6-months post-operatively to detect the effect of mitral valve surgeries over the RV function whether improving, deteriorating, or not changing at all.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Mar 2023

Typical duration for all trials

Status
not yet recruiting

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

Study Progress88%
Mar 2023Nov 2026

First Submitted

Initial submission to the registry

November 12, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

November 12, 2022

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Right Ventricular function post mitral valve surgeries in patients with pulmonary hypertension

    to detect right ventricular function (ejection fraction percentage and/or TAPSE) through transthoracic echocardiography 3- and 6-months post operatively in patients who had mitral valve surgeries with pulmonary hypertension.

    From March 2019 till March 2022

Secondary Outcomes (1)

  • Best mitral valve surgical modalities in patients with pulmonary hypertension

    From March 2019 till March 2022

Interventions

Echocardiography 3 and 6 months post operative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Descriptive cross-sectional

You may qualify if:

  • Patients who underwent mitral valve surgeries who also had pulmonary hypertension in the period between March 2019 and March 2022 in Assiut university heart hospital

You may not qualify if:

  • Patients who underwent mitral valve surgeries with normal pulmonary pressure. Patients who had other valve surgeries besides mitral as aortic and/or tricuspid valve surgeries. Patients had mitral valve surgeries with other heart conditions that needed another intervention in the same session as CABG for IHD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Ho SY. Anatomy of the mitral valve. Heart. 2002 Nov;88 Suppl 4(Suppl 4):iv5-10. doi: 10.1136/heart.88.suppl_4.iv5. No abstract available.

    PMID: 12369589BACKGROUND
  • Tokodi M, Nemeth E, Lakatos BK, Kispal E, Toser Z, Staub L, Racz K, Soltesz A, Szigeti S, Varga T, Gal J, Merkely B, Kovacs A. Right ventricular mechanical pattern in patients undergoing mitral valve surgery: a predictor of post-operative dysfunction? ESC Heart Fail. 2020 Jun;7(3):1246-1256. doi: 10.1002/ehf2.12682. Epub 2020 Mar 26.

    PMID: 32220010BACKGROUND
  • Denault A, Deschamps A, Tardif JC, Lambert J, Perrault L. Pulmonary hypertension in cardiac surgery. Curr Cardiol Rev. 2010 Feb;6(1):1-14. doi: 10.2174/157340310790231671.

    PMID: 21286273BACKGROUND
  • Estrada VH, Franco DL, Moreno AA, Gambasica JA, Nunez CC. Postoperative Right Ventricular Failure in Cardiac Surgery. Cardiol Res. 2016 Dec;7(6):185-195. doi: 10.14740/cr500e. Epub 2016 Dec 31.

    PMID: 28197291BACKGROUND
  • Nagel E, Stuber M, Hess OM. Importance of the right ventricle in valvular heart disease. Eur Heart J. 1996 Jun;17(6):829-36. doi: 10.1093/oxfordjournals.eurheartj.a014963.

    PMID: 8781821BACKGROUND

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

November 12, 2022

First Posted

November 17, 2022

Study Start

March 1, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

February 1, 2023

Record last verified: 2023-01