Coronary Artery DiseasePhase 4NCT01318460
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary Surgery
A Phase 4 study testing Levosimendan infusion in people with Coronary Artery Disease, run by AHEPA University Hospital at 1 site in Greece.
Trial summary
The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Levosimendan infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Mar 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
- age < 79 years old
- left ventricular ejection fraction <= 40%
- informed patient's consent
Who cannot join
- age < 18 years old
- emergency surgery
- medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
- any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
- need for valvular replacement surgery
- redo surgery
- serum creatinine > 2 mg/dl
- history of malignant cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Cardiothoracic Surgery, AHEPA University Hospital
Thessaloniki, 546 36
About this study
Official title: Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery
The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.
Read the detailed description
Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.
Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).
This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.
- Conditions
- Coronary Artery Disease
- Being tested
- Levosimendan infusion, Placebo infusion
- Keywords
- coronary artery disease, levosimendan, coronary artery bypass grafting, cardiac surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levosimendan infusionDrug
Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min
Placebo infusionDrug
Twenty-four hour administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan | Active comparator | Patients treated with prophylactic administration of levosimendan Receives: Drug: Levosimendan infusion |
| Placebo group | Placebo comparator | Patients managed with placebo administration Receives: Drug: Placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function
Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
Measured: Seventh postoperative day
Secondary outcomes (8)
Perioperative mortality
Measured: 30 days postoperatively
Need for intraaortic balloon pump
Measured: 1st-7th postoperative day
Inotropic support
Need for high inotropic support
Measured: 1st-7th postoperative day
Total ICU stay
Measured: 1st-7th postoperative day
Total length of hospital stay
Measured: 1st-7th postoperative day
Time on mechanical ventilation
Measured: 1st-7th postoperative day
Major adverse cardiovascular events
Perioperative myocardial infarction, stroke, need for revascularization)
Measured: 1st-7th postoperative day
Morbidity
Measured: 1st-7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Kyriakos Anastasiadis, AHEPA University Hospital
- Investigators
- Kyriakos Anastasiadis, MD, FETCS, Principal investigator, AHEPA University HospitalChristos Papakonstantinou, MD, Study chair, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318460
- Sponsor's protocol ID
- AHEPA_CTS-03
- Status last verified
- May 2019
- First submitted
- 17 Mar 2011
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.
PubMed 17377079Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.
PubMed 17702589Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9.
PubMed 19592266
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Administration of Levosimendan in Patients With Impaired Left Ventricular Function Undergoing Coronary Surgery
- ClinicalTrials.gov ID
- NCT01318460
- Acronym / sponsor ID
- AHEPA_CTS-03
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, levosimendan, coronary artery bypass grafting, cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 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.
The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.
Detailed description
Myocardial revascularization in patients with impaired left ventricular function remains a serious problem in cardiac surgery. Despite the recent developments with the use of new surgical techniques (mini-extracorporeal circulation, off pump surgery) the perioperative morbidity and mortality are relatively high. Therapeutic solutions with the use of inotropic drugs, as adrenergic agonists and phosphodiesterase inhibitors, have offered important improvement to the hemodynamic status of these patients, but they have not considerably decreased mortality. These drugs owe their positive inotropic action to the increase of intracellular calcium and thereafter they improve the myocardial function.
Levosimendan (SIMDAX) is a new calcium sensitizer which increases the myocardial contractility without particular promotion of the intracellular calcium accumulation. Contemporary experimental and clinical data demonstrated the effectiveness of this drug in the reduction of surgical mortality to the patients with low left ventricular ejection fraction (LVEF) who undergo coronary artery bypass grafting (CABG).
This is an original prospective randomized controlled study focused on the preoperative use of this drug in patients with impaired left ventricular function which is associated with a high operative risk (i.e. EuroSCORE). Perioperative myocardial stunning is particularly evident in this cohort of patients. Prophylactic administration of levosimendan the day before the operation could be translated in improved myocardial performance intraoperatively and during the early postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levosimendan | Active comparator | Drug: Levosimendan infusionPatients treated with prophylactic administration of levosimendan |
| Placebo group | Placebo comparator | Drug: Placebo infusionPatients managed with placebo administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
- age < 79 years old
- left ventricular ejection fraction <= 40%
- informed patient's consent
Key exclusion criteria (8 listed)
- age < 18 years old
- emergency surgery
- medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
- any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
- need for valvular replacement surgery
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 |
|---|---|---|
| Levosimendan infusionProphylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min | Drug | Levosimendan |
| Placebo infusionTwenty-four hour administration of placebo | Drug | Placebo group |
Primary outcome
Left ventricular function
Time frame: Seventh postoperative day
Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day
8 secondary outcomes
Perioperative mortality
Time frame: 30 days postoperatively
Need for intraaortic balloon pump
Time frame: 1st-7th postoperative day
Inotropic support
Time frame: 1st-7th postoperative day
Total ICU stay
Time frame: 1st-7th postoperative day
Total length of hospital stay
Time frame: 1st-7th postoperative day
Time on mechanical ventilation
Time frame: 1st-7th postoperative day
Major adverse cardiovascular events
Time frame: 1st-7th postoperative day
Morbidity
Time frame: 1st-7th postoperative day
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 7 May 2019.
- Background: PubMed 17377079De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.
- Background: PubMed 17702589Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.
- Background: PubMed 19592266Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9.
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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.
Kyriakos Anastasiadis, MD, FETCS principal investigator
AHEPA University Hospital
Christos Papakonstantinou, MD study chair
AHEPA 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 infusion in people with Coronary Artery Disease, run by AHEPA University Hospital at 1 site in Greece.
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 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 7 May 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 Greece. 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 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?
Left ventricular function (time frame: Seventh postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318460, which also lists 3 linked publications.
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 7 May 2019.