Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508683983813 Date of Registration: 05/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Surgical Outcomes of Patients Complaining from Moderate Tricuspid Regurge with Replacement Mitral Valve Regurgitation
Official scientific title Surgical Outcomes of Patients Complaining from Moderate Tricuspid Regurge with Replacement Mitral Valve Regurgitation
Brief summary describing the background and objectives of the trial The primary components of each valvular apparatus include the leaflets, with the tricuspid valve (TV) comprising three such leaflets. TV repair may be necessary if the valve is incompetent, resulting in leakage, or if it fails to open and close properly. Surgical intervention might be required to correct congenital defects or to address valve damage caused by endocarditis, an infection affecting the heart tissue. Tricuspid regurgitation (TR) represents the most frequent indication for TV repair. Given the growing body of evidence demonstrating that untreated severe TR leads to poorer clinical outcomes, there has been an increased focus on the treatment of isolated TV pathologies This study aimed to compare the progression of TV dysfunction following mitral valve replacement in patients with mitral valve regurgitation and concomitant mild to moderate TV regurgitation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 09/01/2024
Actual trial start date
Anticipated date of last follow up 02/05/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mitral valve replacement with TV repair once duration of the operation In the repair group, suture annuloplasty was performed using the Dacron tube technique. All surgeries were carried out under standard aorto-bicaval cannulation, moderate hypothermia, and cold blood cardioplegic arrest via median sternotomy. The procedure utilized a 3-0 extended polytetrafluoroethylene (e-PTFE) suture to secure the Dacron tube with 7 to 9 interrupted sutures, applied without a taphole bridge. Annular size reduction was guided by commercially available cylindrical valve sizers with actual diameters of 29.5 mm, 31.5 mm, and 33.5 mm (corresponding to labeled sizes 27, 29, and 31 mm). Reduction was achieved by tying the interrupted sutures around the inserted sizer within the TV orifice. While the 33.5 mm sizer was used occasionally to prevent excessive constriction, the 31.5 mm sizer was predominantly selected at the surgeon’s discretion. 25
Control Group Mitral valve replacement once duration of the operation Mitral valve replacement only without tricusped repair 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with moderate functional TR secondary to rheumatic mitral valve pathology patients with organic TV involvement, regardless of aetiology, such as congenital defects, trauma, infective endocarditis, or carcinoid syndrome, TV stenosis, undergoing concomitant cardiac surgical procedures other than mitral valve replacement, redo-operation, and low EF< 50%. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 54 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/01/2024 Faculty of Medicine Al Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
Al Azhar University Assiut Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative Cardiac Function Improvement assessed by Changes in tricuspid regurgitation (TR) severity post-surgery (e.g., by echocardiography). Assessment of right ventricular function (e.g., TAPSE, RV size). and assessment of Left ventricular function if affected secondarily. Overall Surgical Outcome: In-hospital mortality or 30-day mortality and Success of mitral valve replacement and impact on tricuspid regurgitation. during their hospital stay and one week after surgery, followed by visits at three months, six months, and one year postoperatively
Secondary Outcome Functional Status Improvement: Change in New York Heart Association (NYHA) functional class and Improvement in symptoms such as fatigue, dyspnea, and peripheral edema. Echocardiographic Parameters Over Time: Incidence of arrhythmias, renal dysfunction, ICU stay, and reoperation.Length of hospital stay. during their hospital stay and one week after surgery, followed by visits at three months, six months, and one year postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic Surgery Department Al Azhar University Hospital Assiut Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar University Hospital Assiut Al Azhar University Hospital Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University hospital Al Azhar University hospital assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Farouk Ragab faroukf850@gmail.com +201027200666 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant lecturer of Cardiothoracic Surgery Al Azhar University assiut
Role Name Email Phone Street address
Scientific Enquiries Alaa Gad El Karem alaashandwely85@yahoo.com +201144447785 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor of Cardiothoracic surgery Al Azhar University Assiut
Role Name Email Phone Street address
Public Enquiries Adel Khalaf Dr.adel_khalaf@hotmail.com +201001828776 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor of Cardiothoracic surgery Al Azhar University Assiut
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results of this study will be available after deidentification (text, tables, figures) Clinical Study Report,Informed Consent Form,Study Protocol data will be available 3 months and up to 12 months after article publications qualified persons only
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information