Cardiac SurgeryPhase 2NCT06784570
Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction
A Phase 2 study testing levosemindan and adrenaline,noreadrenaline,dopamine and doputamine in people with Cardiac Surgery and Low Ejection Fraction, run by Zagazig University at 1 site in Egypt.
Trial summary
to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart) Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cardiac Surgery, Low Ejection Fraction
- What is being tested?
- levosemindan and adrenaline,noreadrenaline,dopamine and doputamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Aug 2024
- Phase
- Phase 2
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Valve surgery
- CABG surgery,
- combined surgery
- all patients Ejection Fraction less than 35 ٪ -
Who cannot join
- Patients age ≤ 20-70 < years
- Aortic and redo surgery
- any patients with Ejection Fraction more than 35 ٪ -
Trial locations and contacts
1 site in 1 country.
Egypt1 site
cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt
Zagazig, Sharqia Province, 44519
About this study
to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)
Read the detailed description
in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)
- Conditions
- Cardiac Surgery, Low Ejection Fraction
- Being tested
- levosemindan, adrenaline,noreadrenaline,dopamine and doputamine
- Keywords
- levosemindan- low ejection fraction-cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosemindanDrug
In common practice the loading dose is omitted as it is associated with hypotension.9 Usual dose range: 0.05 to 0.2 microg/kg/min. Dose based on actual body weight up to a maximum of 120 kg.5 Commence infusion at 0.05 microg/kg/min. If the initial rate is tolerated, consider increasing the maintenance rate to 0.1 microg/kg/min after 60 minutes. If the patient remains haemodynamically stable, further increase the dose to 0.2 microg/kg/min for the remainder of the infusion.
adrenaline,noreadrenaline,dopamine and doputamineDrug
adrenaline:*4 9 %$ 0 ****8*4* 9 : ,- 4 - *4 9 * C % F*4 9 9 9 noreadrenaline:# *4 9 C % 9 F 9 9 *4* Q*4 9 9 dopamine:9 * C % 9 F 9 9 ) * 9 9 dobutamine:9 * C % F 9 9 9 * 9 9
| Study group | Role | What they receive |
|---|---|---|
| levosemindan | Experimental | this group of patients will recieve levosemindan Receives: Drug: levosemindan |
| traditional | Active comparator | this group of patients will recieve traditional intropic drugs Receives: Drug: adrenaline,noreadrenaline,dopamine and doputamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
death through day 30,
death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery
Measured: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )
Renal-replacement therapy
included haemodialysis, peritoneal dialysis, or continuous Veno venous haemodialysis(indicated when serum creatinine above 2.0 mg/dl or an increase of 50% above baseline value)
Measured: 1 month
Perioperative myocardial infarction
defined as a creatine kinase MB level of more than 100 ng per millilitre or a level that was more than 10 times the upper limit of the normal range specified at the local laboratory, regardless of changes on the electrocardiogram, or a creatine kinase MB level that was more than 50 ng per millilitre or a level that was more than 5 times the upper limit of the normal range with new Q waves that were more than 30 msec in duration in two contiguous leads or new left bundle-branch block
Measured: 5 days
Intra Aortic Ballon Pumb insertion
it consisidered to be one of the ventricular assissted device that need to be inserted in post cardiac surgery shocked patiients that not respond heamdynamically to highest doses of cardiac intropes
Measured: 5 days(no scale for measurement )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2021
- Primary completion1 Mar 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients divided into three groups according to type of surgery done : CABG alone, Valve alone and combined each group contains 80 patients, then each previous group is subdivided into LEVO group and TRAD group each subgroup contain 40 patients according to the type of inotropes used in each group either levosemindane (pre operative ) or other traditional adrenergic drugs :adrenaline ,noradrenaline ,dopamine and dobutamine
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed Ibrahim Mohamed El Anwar, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784570
- Sponsor's protocol ID
- ZU-IRB # 737/15-oct-2024
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction
- ClinicalTrials.gov ID
- NCT06784570
- Acronym / sponsor ID
- ZU-IRB # 737/15-oct-2024
- Conditions
- Cardiac Surgery, Low Ejection Fraction
- Keywords
- levosemindan- low ejection fraction-cardiac surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 20 Jan 2025 (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.
to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)
Detailed description
in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients divided into three groups according to type of surgery done : CABG alone, Valve alone and combined each group contains 80 patients, then each previous group is subdivided into LEVO group and TRAD group each subgroup contain 40 patients according to the type of inotropes used in each group either levosemindane (pre operative ) or other traditional adrenergic drugs :adrenaline ,noradrenaline ,dopamine and dobutamine
| Arm | Type | Receives |
|---|---|---|
| levosemindan | Experimental | Drug: levosemindanthis group of patients will recieve levosemindan |
| traditional | Active comparator | Drug: adrenaline,noreadrenaline,dopamine and doputaminethis group of patients will recieve traditional intropic drugs |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Valve surgery
- CABG surgery,
- combined surgery
- all patients Ejection Fraction less than 35 ٪ -
Key exclusion criteria (3 listed)
- Patients age ≤ 20-70 < years
- Aortic and redo surgery
- any patients with Ejection Fraction more than 35 ٪ -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levosemindanIn common practice the loading dose is omitted as it is associated with hypotension.9 Usual dose range: 0.05 to 0.2 microg/kg/min. Dose based on actual body weight up to a maximum of 120 kg.5 Commence infusion at 0.05 microg/kg/min. If the initial rate is tolerated, consider increasing the maintenance rate to 0.1 microg/kg/min after 60 minutes. If the patient remains haemodynamically stable, further increase the dose to 0.2 microg/kg/min for the remainder of the infusion. | Drug | levosemindan |
| adrenaline,noreadrenaline,dopamine and doputamineadrenaline:*4 9 %$ 0 ****8*4* 9 : ,- 4 - *4 9 * C % F*4 9 9 9 noreadrenaline:# *4 9 C % 9 F 9 9 *4* Q*4 9 9 dopamine:9 * C % 9 F 9 9 ) * 9 9 dobutamine:9 * C % F 9 9 9 * 9 9 | Drug | traditional |
Primary outcome
death through day 30,
Time frame: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )
death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery
Renal-replacement therapy
Time frame: 1 month
included haemodialysis, peritoneal dialysis, or continuous Veno venous haemodialysis(indicated when serum creatinine above 2.0 mg/dl or an increase of 50% above baseline value)
Perioperative myocardial infarction
Time frame: 5 days
defined as a creatine kinase MB level of more than 100 ng per millilitre or a level that was more than 10 times the upper limit of the normal range specified at the local laboratory, regardless of changes on the electrocardiogram, or a creatine kinase MB level that was more than 50 ng per millilitre or a level that was more than 5 times the upper limit of the normal range with new Q waves that were more than 30 msec in duration in two contiguous leads or new left bundle-branch block
Intra Aortic Ballon Pumb insertion
Time frame: 5 days(no scale for measurement )
it consisidered to be one of the ventricular assissted device that need to be inserted in post cardiac surgery shocked patiients that not respond heamdynamically to highest doses of cardiac intropes
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 20 Jan 2025.
- Individual participant dataSharing planned: No
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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?
A Phase 2 study testing levosemindan and adrenaline,noreadrenaline,dopamine and doputamine in people with Cardiac Surgery and Low Ejection Fraction, run by Zagazig 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 4 inclusion and 3 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 20 Jan 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
death through day 30, (time frame: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )). The study lists 4 primary outcomes in all. 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 20 Jan 2025.