NCT07416331Completed
Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 52 (actual)
- First submitted
- 23 Jan 2026
- Start date
- 1 Aug 2024
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Helwan University
- NCT number
- NCT07416331
What you commit to
- Study type: Observational
- Participants enrolled: 52
- From 1 Aug 2024 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery,
Lab values
- 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.
- Uncontrolled diabetes mellitus (HBA1C more than 8 )
Other
- Potential pregnancy.
- Refusal to participate.
- Requiring preoperative inotropes.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Helwan University Coordinator of this site? Confirm its status | Giza | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.