Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery

NCT07416331 | Completed DMC

• 2 other identifiers: IORG registry num: IORG0011670REC faculty of medicine helwan
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Right Ventriculaire Dysfunction; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Giza, 12566, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 18, 2026
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)