Heart Valve DiseasePhase 4NCT01210976
The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting (CABG) Surgery
A Phase 4 study testing levosimendan in people with Heart Valve Disease, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- levosimendan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Sep 2010
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm
Who cannot join
- allergy to levosimendan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.
Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.
- Conditions
- Heart Valve Disease
- Being tested
- levosimendan, placebo
- Keywords
- levosimendan, CABG, AVR
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min
placeboDrug
nacl 0.9% coloured with thiamin in same volume and time than levosimendan
| Study group | Role | What they receive |
|---|---|---|
| levosimendan | Experimental | Not described Receives: Drug: levosimendan |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: up to 5 days
Secondary outcomes (1)
echocardiography
Measured: baseline, 1st and 5th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heli Leppikangas, MD, Principal investigator, Department of Anaesthesia, Tampere UHKati Järvelä, MD,PhD, Study chair, Heart Center, Pirkanmaa Hospital DistrictTero Sisto, MD, PhD, Study chair, Heart Center, Pirkanmaa Hospital DistrictPasi Maaranen, MD, Study chair, Heart Center, Pirkanmaa Hospitla DistrictPasi Lehto, MD,PhD, Study chair, Heart Center, Pirkanmaa Hospital DistrictMarko Virtanen, MD,PhD, Study chair, Heart Center, Pirkanmaa Hospital DistrictSari Karlsson, MD, Study chair, Department of Intensive Care, Tampere UHEsko Ruokonen, MD,PhD, Study chair, Department of Intensive Care, Kuopio UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210976
- Sponsor's protocol ID
- R08039M
- Status last verified
- Sep 2011
- First submitted
- 24 Sep 2010
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Leppikangas H, Jarvela K, Sisto T, Maaranen P, Virtanen M, Lehto P, Karlsson S, Koobi T, Lindgren L. Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery. Br J Anaesth. 2011 Mar;106(3):298-304. doi: 10.1093/bja/aeq402. Epub 2011 Jan 21.
PubMed 21258075
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Levosimendan on Haemodynamics in Patients Undergoing Elective Aortic Valve Replacement (AVR)Together With Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT01210976
- Acronym / sponsor ID
- R08039M
- Conditions
- Heart Valve Disease
- Keywords
- levosimendan, CABG, AVR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 29 Sep 2010 (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.
Patients undergoing aortic valve replacement (AVR) surgery with coronary artery bypass grafting (CABG) are at risk of left ventricular dysfunction. The aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (AVR) together with coronary artery bypass grafting (CABG) surgery. The study is randomized, double-blinded, placebo-controlled and will be carried out in Heart Center.
Twenty four patients will be randomized into two groups of 12. The treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. The splanchnic perfusion will be measured by the means of vena hepatica cannulation. CircMon B202 (JR Medical Ltd, Tallinn, Estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (SVRI), and extracellular water (ECW). Surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. Echo cardiography will be done pre- and postoperatively. Haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.
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 | Experimental | Drug: levosimendan |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- LVEF less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm
Key exclusion criteria (1 listed)
- allergy to levosimendan
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 |
|---|---|---|
| levosimendan12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min | Drug | levosimendan |
| placebonacl 0.9% coloured with thiamin in same volume and time than levosimendan | Drug | placebo |
Primary outcome
blood pressure
Time frame: up to 5 days
1 secondary outcome
echocardiography
Time frame: baseline, 1st and 5th 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 21 Sep 2011.
- Derived from this study: PubMed 21258075Leppikangas H, Jarvela K, Sisto T, Maaranen P, Virtanen M, Lehto P, Karlsson S, Koobi T, Lindgren L. Preoperative levosimendan infusion in combined aortic valve and coronary bypass surgery. Br J Anaesth. 2011 Mar;106(3):298-304. doi: 10.1093/bja/aeq402. Epub 2011 Jan 21.
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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.
Heli Leppikangas, MD principal investigator
Department of Anaesthesia, Tampere UH
Kati Järvelä, MD,PhD study chair
Heart Center, Pirkanmaa Hospital District
Tero Sisto, MD, PhD study chair
Heart Center, Pirkanmaa Hospital District
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 in people with Heart Valve Disease, 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 1 inclusion and 1 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 21 Sep 2011. 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 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?
blood pressure (time frame: up to 5 days). 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 NCT01210976, which also lists 1 linked publication.
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 21 Sep 2011.