Evaluation of Right Ventricular Function Post Mitral Valve Operations

Right Ventricular Dysfunction Clinical Trial

Official title:

Evaluation of Right Ventricular Function Post Mitral Valve Operations in Patients With Pulmonary Hypertension.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05620992
• Other study ID #: Right ventricular function
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: November 1, 2026

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Device:
• Echocardiography
Echocardiography 3 and 6 months post operative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From March 2019 till March 2022