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NCT Number: NCT07836426

Does the Pericardial Closure Reduces Early Right Ventricular Dysfunction After Cardiac Surgery: A Randomized Controlled Trial

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.

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Key information

Conditions

Effect of Pericardial Closure on the Right Ventricular Function Post Cardiac Surgery Open Heart Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University hospital

Asyut, Egypt

Location contact

Assiut Assuit university hospital

CONTACT

[email protected]

00201060048430

abdelrahaman hamed Ahmed

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

• right ventricular dysfunction

RV dilatation (RV diameter > 4.5)
RV infarction
pacemaker stimulation,
severe left heart insufficiency (LV-EF ≤ 40%).
tricuspid valve insufficiency > 2°.
pulmonary valve insufficiency ≥2°,
atrial fibrillation/flutter,
pulmonary hypertension,
state after pulmonary artery embolism.
chronic obstructive pulmonary disease > GOLD 2, prior cardiac surgery.

Treatment and study plan

close pericardium

Procedure

close pericardium by continuous sutures before sternal closure

Primary outcomes

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

Secondary outcomes

the postoperative LV function after pericardial closure vs. open pericardium

Time frame: 3 months

by assessing ejection fraction by early postoperative echocardiography

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahamn Hamed Abdelrahman hamed

CONTACT

[email protected]

00201060048430

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Sep 23, 2026
Registry last updated: Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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