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Not yet recruitingNCT05620992Updated Feb 1, 2023

Evaluation of Right Ventricular Function Post Mitral Valve Operations

An observational study in Right Ventricular Dysfunction, sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
50
Sex
All
01

Study 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.

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Conditions studied

  • Right Ventricular Dysfunction
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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Descriptive cross-sectional

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DeviceEchocardiography

    Echocardiography 3 and 6 months post operative

05

What researchers measure

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.

    Time frame: From March 2019 till March 2022

Secondary outcomes

  1. Best mitral valve surgical modalities in patients with pulmonary hypertension

    to identify best surgical modalities for mitral valve diseased patients with pulmonary hypertension that lead to improvement of right ventricle function.

    Time frame: From March 2019 till March 2022

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 12369589 ↗
  • 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. PubMed 32220010 ↗
  • 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. PubMed 21286273 ↗
  • 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. PubMed 28197291 ↗
  • 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. PubMed 8781821 ↗
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Registry details

Key details

Study ID
NCT05620992
Lead sponsor
Assiut University
Responsible party
Mohammad Ali Mohammad Abdelbakey (Resident, Assiut University) — Principal investigator
First posted
Nov 17, 2022
Start date
Mar 1, 2023 (estimated)
Primary completion
Nov 1, 2025 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Feb 1, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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