Myocardial StunningPhase 4NCT01500785
Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
A Phase 4 study testing levosimendan and Vitamin B 12 in people with Myocardial Stunning, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Stunning
- What is being tested?
- levosimendan and Vitamin B 12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- 15 Jun 2018to 11 Sep 2019
- Phase
- Phase 4
- 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
Who may be able to join
- preoperative LVEF 40% or less
- septal wall thickness more than 11mm
- less than moderate aortic insufficiency
- sinus rhythm before CPB
Who cannot join
- oesophageal disease
- known allergy to levosimendan or its metabolites or adjuvants.
Trial locations and contacts
1 site in 1 country.
About this study
Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.
The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
- Conditions
- Myocardial Stunning
- Being tested
- levosimendan, Vitamin B 12
- Medical subject headings
- Myocardial Stunning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Also called Simdax (manufacturer: Orion Corporation), CO1CX08
infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient)
Vitamin B 12Drug
Also called Soluvit (B05XC)
Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient).
| Study group | Role | What they receive |
|---|---|---|
| levosimendan | Active comparator | Not described Receives: Drug: levosimendan |
| placebo | Placebo comparator | Not described Receives: Drug: Vitamin B 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cardiac output
Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
Measured: from baseline to 15min after weaning from CPB
Secondary outcomes (2)
EF
Secondary endpoint is a change in LV ejection fraction (EF) from baseline (after induction of anesthesia) to 5 min after sternal closure.
Measured: from baseline to 5 min after sternal closure
cTnT/CK-MB on the first postoperative morning.
Secondary endpoint is a change in cTnT/CK-MB on the first postoperative morning.
Measured: from baseline to 1st post. op. morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start15 Jun 2018
- Primary completion15 Dec 2018
- Study completion11 Sep 2019
Why it stopped: Change of schedule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial StunningStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panu Virkkala, MD, Principal investigator, Heart Center Co. Tampere university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500785
- Sponsor's protocol ID
- HCA-2011-1-3
- Other IDs
- 2011-002643-10
- Status last verified
- Sep 2019
- First submitted
- 22 Dec 2011
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracoronary Administration of Levosimendan in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01500785
- Acronym / sponsor ID
- HCA-2011-1-3
- Conditions
- Myocardial Stunning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change of schedule
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 28 Dec 2011 (estimated)
- 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.
Incomplete recovery from ischemia causes stunned myocardium. Ischemia may be due to coronary artery disease or aortic cross-clamping during surgery. Stunning leads to myocardial dysfunction. It has been suggested that the mechanism responsible for the contractile depression in stunned myocardium is a decreased sensitivity of the myofibrils to calcium. Levosimendan is a calcium sensitizer, which has been shown to improve the function of stunned myocardium without obvious impairment of diastolic function. Systemic vasodilation and need of vasoconstrictive medication is usually apparent after administration of levosimendan. Colucci et al have demonstrated that with intracoronary administration of milrinone, another inodilator, systemic vasodilation could be excluded. If this is true with levosimendan, it may be possible to improve left ventricular hypo/dyskinesia without afterload reduction by adding levosimendan into cardioplegia solution.
The investigators hypotize that levosimendan, delivered together with cardioplegia, can improve LV dysfunction after opening of aortic cross-clamp in patients undergoing aortic valve and coronary artery bypass operation. Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline. Secondary endpoints are a change in LV ejection fraction from baseline to 5 min after sternal closure and cTnT/CK-MB on the first postoperative morning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levosimendan | Active comparator | Drug: levosimendan |
| placebo | Placebo comparator | Drug: Vitamin B 12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- preoperative LVEF 40% or less
- septal wall thickness more than 11mm
- less than moderate aortic insufficiency
- sinus rhythm before CPB
Key exclusion criteria (2 listed)
- oesophageal disease
- known allergy to levosimendan or its metabolites or adjuvants.
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 |
|---|---|---|
| levosimendanAlso: Simdax (manufacturer: Orion Corporation), CO1CX08infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient) | Drug | levosimendan |
| Vitamin B 12Also: Soluvit (B05XC)Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient). | Drug | placebo |
Primary outcome
change in cardiac output
Time frame: from baseline to 15min after weaning from CPB
Our primary endpoint is a change in cardiac output 15 min after separation from cardiopulmonary bypass compared to the baseline (after induction of anesthesia).
2 secondary outcomes
EF
Time frame: from baseline to 5 min after sternal closure
cTnT/CK-MB on the first postoperative morning.
Time frame: from baseline to 1st post. op. morning
Results and safety
The study was stopped early (reason given: Change of schedule). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
Related trials for Myocardial Stunning
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RecruitingObservational study
Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy
RecruitingObservational study
Stunning in Takotsubo Versus Acute Myocardial Infarction
Myocardial Stunning
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.
Panu Virkkala, MD principal investigator
Heart Center Co. Tampere university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing levosimendan and Vitamin B 12 in people with Myocardial Stunning, run by Tampere University Hospital at 1 site in Finland.
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 2 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: stopped early, as of the sponsor's last update on 13 Sep 2019. 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 Finland. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Change of schedule). Results are not available in the source record.
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?
change in cardiac output (time frame: from baseline to 15min after weaning from CPB). 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 13 Sep 2019.