Right Ventriculaire Dysfunctionrt side failurNCT07416331
Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery
An observational study of Right Ventriculaire Dysfunction and Pulmonary Hypertension, run by Helwan University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventriculaire Dysfunction, Pulmonary Hypertension
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the end of treatment at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Aug 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventriculaire DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelkader Abdelrahman Abdelkader Elbakry, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416331
- Sponsor's protocol ID
- IORG registry num: IORG0011670
- Other IDs
- REC faculty of medicine helwan
- Acronym
- rt side failur
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT07416331
- Acronym / sponsor ID
- rt side failur / IORG registry num: IORG0011670
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post operative change of right ventricular function during 1 week after surgery mesured by ECHO parameters
Time frame: from enrollment to the end of treatment at 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventriculaire Dysfunction and Pulmonary Hypertension, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative change of right ventricular function during 1 week after surgery mesured by ECHO parameters (time frame: from enrollment to the end of treatment at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.