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Clinical Trials/NCT07836426
NCT07836426Not yet recruitingNot Applicable

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

Assiut University1 site in 1 country90 target enrollmentStarted: December 10, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
90
Locations
1
Primary Endpoint
Tricuspid annular plane systolic excursion (TAPSE)

Study Overview

Brief 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]. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

intervention

Experimental

closed pericardium

Intervention: close pericardium (Procedure)

control

No Intervention

open pericardium

Outcomes

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(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdelrahman Hamed Ahmed

Abdelrahaman Hamed Ahmed Mohamed

Assiut University

Study Sites (1)

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