Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery (rt side failur)

in this prospective, randomized, controlled double blinded study conducted at Helwan University Hospitals include 52 patients with rheumatic mitral and/or aortic valve disease and pulmonary arterial hypertension at the start of rewarming, patients will be randomly assigned into either group 1 (levosimendan) or group 2 (dobutamine ) Group 1 patients will receive dobutamine, 3-5 microgram/kg group 2 patients will receive levosimendan 6 ug/kg bolus over 10 minutes, followed by infusion at a rate of 0.1 mg/kg/min Transthoracic echocardiography performed before induction of anaesthesia (baseline), 6 and 12 hours post surgery . In addition, transthoracic echocardiography also performed 24 hours post extubating. Transoesophageal echocardiography (TEE) examination performed during the intraoperative period before the initiation of CPB (pre CPB) and 30 minutes after separation from CPB (post-CPB) Echocardiographic parameters measured will include tricuspid annular plane systolic excursion (TAPSE), Tei index and myocardial systolic velocities at the tricuspid annulus (S/) for the assessment of right ventricular systolic function, and ratio of tricuspid inflow to tricuspid annular diastolic velocity (E/E/) for the assessment of right ventricular diastolic function.

Pulmonary artery pressure will be assessed frequently by transthoracic echo during every assessment.

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension; Right Ventriculaire Dysfunction

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12566
    • Helwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients scheduled for valve replacement surgery with PAH (an estimated right ventricular systolic pressure more than 50 mmHg, or mean PAP more than 40 mmHg, or systolic PAP exceeding 50% of systemic systolic pressure). Pregnant Patients or .

Patients with severe renal dysfunction (GFR 15 to 29 ml/min per 1.73 m2 )or Severe hepatic or patients with Uncontrolled diabetes mellitus (HBA1C more than 8 )or patients needed inotropic support before surgery were excluded from the study.

Description

Inclusion Criteria:

• Age ≥18 years
• Undergoing mitral and/or aortic valve replacement
• PAH (an estimated right ventricular systolic pressure more than 50 mmHg, or mean PAP more than 40 mmHg, or systolic PAP exceeding 50% of systemic systolic pressure).

Exclusion Criteria:

• Potential pregnancy.
• Refusal to participate.
• Patients with severe renal dysfunction (GFR 15 to 29 ml/min per 1.73 m2 )
• Severe hepatic dysfunction.( Grade 4: AST/ALT >20.0 x(upper limit normal )
• Prolonged QT interval.
• Emergency surgery,
• Requiring preoperative inotropes.
• Uncontrolled diabetes mellitus (HBA1C more than 8 )

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
group 1(levosimendan); group 1 (levosimendan) Group 1 will receive levosimendan 6 ug/kg bolus over 10 minutes, followed by infusion at a rate of 0.1 mg/kg/min
Group 2 (dobutamine); r group 2 (dobutamine ) Group 2 patients will receive dobutamine, 3-5 microgram/kg group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative change of right ventricular function during 1 week after surgery mesured by ECHO parameters	echocardiographic parameters include ,TAPSE( tricused annular plane excursion in cm) , Tei index, myocardial systolic velocities at the tricuspid annulus S/in cm/s , ratio of tricuspid inflow to tricuspid annular diastolic velocity (E/e/) those parameters will be combined for the assessment of right ventricular function.	from enrollment to the end of treatment at 1 week

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: IORG registry num: IORG0011670; REC faculty of medicine helwan (Registry Identifier: IORG0011670)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No