- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05620992
Evaluation of Right Ventricular Function Post Mitral Valve Operations
November 12, 2022 updated by: Mohammad Ali Mohammad Abdelbakey, Assiut University
Evaluation of Right Ventricular Function Post Mitral Valve Operations in Patients With Pulmonary Hypertension.
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Descriptive cross-sectional
Description
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Right Ventricular function post mitral valve surgeries in patients with pulmonary hypertension
Time Frame: From March 2019 till March 2022
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best mitral valve surgical modalities in patients with pulmonary hypertension
Time Frame: From March 2019 till March 2022
|
to identify best surgical modalities for mitral valve diseased patients with pulmonary hypertension that lead to improvement of right ventricle function.
|
From March 2019 till March 2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
November 1, 2025
Study Completion (Anticipated)
November 1, 2026
Study Registration Dates
First Submitted
November 12, 2022
First Submitted That Met QC Criteria
November 12, 2022
First Posted (Actual)
November 17, 2022
Study Record Updates
Last Update Posted (Actual)
November 17, 2022
Last Update Submitted That Met QC Criteria
November 12, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Right ventricular function
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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