Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac SurgeryNCT07836426
Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial
A study testing close pericardium in people with Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery and Open Heart Surgery, run by Assiut University at 1 site in Egypt.
Trial summary
The right ventricular (RV) function has a major influence on the outcomes of cardiac surgery[1,2]. Also affects the prognosis of patients undergoing heart surgery, where the development of right ventricular failure after surgery is linked to higher rates of morbidity and mortality[3]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery, Open Heart Surgery
- What is being tested?
- close pericardium
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing following surgeries
- aortic valve replacement (AVR).
- mitral valve replacement (MVR).
- combined coronary and/or valvular heart surgeries.
- coronary artery by-pass graft (CABG).
Who cannot join
- • right ventricular dysfunction
- RV dilatation (RV diameter > 4.5)
- RV infarction
- pacemaker stimulation,
- severe left heart insufficiency (LV-EF ≤ 40%).
- tricuspid valve insufficiency > 2°.
Show all 11Show fewer
- pulmonary valve insufficiency ≥2°,
- atrial fibrillation/flutter,
- pulmonary hypertension,
- state after pulmonary artery embolism.
- chronic obstructive pulmonary disease > GOLD 2, prior cardiac surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut University hospital
Asyut
Assiut Assuit university hospital, 00201060048430, abdelrahman.hamed.ed@gmail.com
abdelrahaman hamed Ahmed
About this study
The right ventricular (RV) function has a major influence on the outcomes of cardiac surgery[1,2]. Also affects the prognosis of patients undergoing heart surgery, where the development of right ventricular failure after surgery is linked to higher rates of morbidity and mortality[3]. Significant clinical consequences result from perioperative impairment of RV function, including increased need for inotropic support, prolonged intensive care unit admission, higher rates of hospital readmission, and a higher risk of in-hospital mortality.[2,4]. Regardless of the use of cardiopulmonary bypass, longitudinal evaluations of RV systolic function, such as tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular systolic velocity (TASV/S'), frequently decrease following elective coronary artery bypass grafting (CABG) [6,7]. Loss of pericardial restriction during pericardiotomy, ischemia from inadequate myocardial protection, and postoperative adhesions that modify RV shape and contraction patterns are theories explaining these perioperative alterations [4,8]. This study employed standard transthoracic echocardiography and speckle-tracking deformation analysis for the assessment of the effect of closing the pericardium on RV function post operatively versus leaving it open.
- Conditions
- Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery, Open Heart Surgery
- Being tested
- close pericardium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
close pericardiumProcedure or surgery
close pericardium by continuous sutures before sternal closure
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | closed pericardium Receives: Procedure: close pericardium |
| control | No intervention | open pericardium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tricuspid annular plane systolic excursion (TAPSE)
to asses the effect of pericardial closure on the right ventricular function
Measured: 3 months
Tricuspid annular systolic velocity TASV/S'
to asses the effect of pericardial closure on right ventricular function
Measured: 3 month
Secondary outcomes (1)
the postoperative LV function after pericardial closure vs. open pericardium
by assessing ejection fraction by early postoperative echocardiography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start10 Dec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836426
- Sponsor's protocol ID
- Pericardial Closure postop
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: according to the need of explanation
Publications
Bootsma IT, Scheeren TWL, de Lange F, Jainandunsing JS, Boerma EC. The Reduction in Right Ventricular Longitudinal Contraction Parameters Is Not Accompanied by a Reduction in General Right Ventricular Performance During Aortic Valve Replacement: An Explorative Study. J Cardiothorac Vasc Anesth. 2020 Aug;34(8):2140-2147. doi: 10.1053/j.jvca.2020.01.012. Epub 2020 Jan 15.
PubMed 32139346Merlo A, Cirelli C, Vizzardi E, Fiorendi L, Roncali F, Marino M, Merlo M, Senni M, Sciatti E. Right Ventricular Dysfunction before and after Cardiac Surgery: Prognostic Implications. J Clin Med. 2024 Mar 11;13(6):1609. doi: 10.3390/jcm13061609.
PubMed 38541835Breuer H, Sales MC, Ramnath NWM, Shieba Y, Kolashov A, Moza A, Tewarie L, Zayat R, Hatam N. Pericardial Closure Preserves Early Right Ventricular Function After Cardiac Surgery: A Retrospective Cohort Study. J Cardiovasc Dev Dis. 2025 Oct 31;12(11):431. doi: 10.3390/jcdd12110431.
PubMed 41295357
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07836426
- Acronym / sponsor ID
- Pericardial Closure postop
- Conditions
- Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery, Open Heart Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The right ventricular (RV) function has a major influence on the outcomes of cardiac surgery[1,2]. Also affects the prognosis of patients undergoing heart surgery, where the development of right ventricular failure after surgery is linked to higher rates of morbidity and mortality[3]. Significant clinical consequences result from perioperative impairment of RV function, including increased need for inotropic support, prolonged intensive care unit admission, higher rates of hospital readmission, and a higher risk of in-hospital mortality.[2,4]. Regardless of the use of cardiopulmonary bypass, longitudinal evaluations of RV systolic function, such as tricuspid annular plane systolic excursion (TAPSE) and tricuspid annular systolic velocity (TASV/S'), frequently decrease following elective coronary artery bypass grafting (CABG) [6,7]. Loss of pericardial restriction during pericardiotomy, ischemia from inadequate myocardial protection, and postoperative adhesions that modify RV shape and contraction patterns are theories explaining these perioperative alterations [4,8]. This study employed standard transthoracic echocardiography and speckle-tracking deformation analysis for the assessment of the effect of closing the pericardium on RV function post operatively versus leaving it open.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: close pericardiumclosed pericardium |
| control | No intervention | –open pericardium |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing following surgeries
Key exclusion criteria (11 listed)
- • right ventricular dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| close pericardiumclose pericardium by continuous sutures before sternal closure | Procedure or surgery | intervention |
Primary outcome
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: 3 months
to asses the effect of pericardial closure on the right ventricular function
Tricuspid annular systolic velocity TASV/S'
Time frame: 3 month
to asses the effect of pericardial closure on right ventricular function
1 secondary outcome
the postoperative LV function after pericardial closure vs. open pericardium
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Background: PubMed 32139346Bootsma IT, Scheeren TWL, de Lange F, Jainandunsing JS, Boerma EC. The Reduction in Right Ventricular Longitudinal Contraction Parameters Is Not Accompanied by a Reduction in General Right Ventricular Performance During Aortic Valve Replacement: An Explorative Study. J Cardiothorac Vasc Anesth. 2020 Aug;34(8):2140-2147. doi: 10.1053/j.jvca.2020.01.012. Epub 2020 Jan 15.
- Background: PubMed 38541835Merlo A, Cirelli C, Vizzardi E, Fiorendi L, Roncali F, Marino M, Merlo M, Senni M, Sciatti E. Right Ventricular Dysfunction before and after Cardiac Surgery: Prognostic Implications. J Clin Med. 2024 Mar 11;13(6):1609. doi: 10.3390/jcm13061609.
- Background: PubMed 41295357Breuer H, Sales MC, Ramnath NWM, Shieba Y, Kolashov A, Moza A, Tewarie L, Zayat R, Hatam N. Pericardial Closure Preserves Early Right Ventricular Function After Cardiac Surgery: A Retrospective Cohort Study. J Cardiovasc Dev Dis. 2025 Oct 31;12(11):431. doi: 10.3390/jcdd12110431.
- Individual participant dataSharing planned: Undecided. according to the need of explanation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing close pericardium in people with Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery and Open Heart Surgery, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahamn Hamed Abdelrahman hamed (00201060048430, abdelrahman.hamed.ed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tricuspid annular plane systolic excursion (TAPSE) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07836426, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.