Myocardial InfarctionPhase 4NCT00324766
Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.
A Phase 4 study testing levosimendan in people with Myocardial Infarction and Heart Failure, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myocardial Infarction, Heart Failure, Cardiogenic Shock
- 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
- 61 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2006to Mar 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
- Revascularization by PCI,
- Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
- Dyspnoea at rest and one of the following:
- pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.
- Subgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.
Who cannot join
- Age below 20 years
- Heart rate above 120 bpm
- Septic shock
- ARDS
- Creatinine >450 micromol/l
- Hepatic impairment
Show all 10Show fewer
- Significant mechanical outlet obstruction
- Allergy against study drug medication
- Anaemia (Hb <8 g/dl)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Cardiology, Ulleval University Hospital
Oslo, N-0852
About this study
Official title: Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.
The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.
Read the detailed description
Double blind placebo-controlled study with parallel groups in patients with acute PCI treated myocardial infarction complicated with decompensated heart failure. The study include a prospectively defined subgroup of patients in cardiogenic shock. Treating acute myocardial infarction with PCI restores blood flow, but decreased contractility remains for hours and days due to stunned myocardium. Levosimendan has both inotropic and vasodilatory effects which could support the failing heart after treating the acute myocardial infarction with PCI and may improve myocardial stunning and decrease pro-inflammatory cytokines. Levosimendan could improve myocardial contractility, symptoms and outcome without adverse effects. The aims of the study are to investigate whether a 24 hour infusion with levosimendan could improve regional contractility measured by echocardiography, improve BNP levels, reduce the levels of pro-inflammatory cytokines and improve symptoms in patients with acute decompensated heart failure during the first 24 hours after acute PCI.
- Conditions
- Myocardial Infarction, Heart Failure, Cardiogenic Shock
- Being tested
- levosimendan, placebo,
- Medical subject headings
- Myocardial Infarction, Heart Failure, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levosimendanDrug
Also called Simdax
1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min
placebo,Drug
Also called placebo
24 h, infusion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | levosimendan Receives: Drug: levosimendan |
| 2 | Placebo comparator | Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min Receives: Drug: placebo, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.
Changes in regional contractility (WMSI) measured by echo is the primary endpoint in the study and the sample size calculation is based on expected differenced in WMSI from baseline to day 5 between groups.
Measured: At 5 days
Secondary outcomes (11)
Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.
Measured: 6 months
Time to rehospitalisation for decompensated heart failure.
Measured: 6 months
Days hospitalised/days in intensive/coronary care.
Measured: At discharge
Changes in inflammation markers.
Measured: 1, 5 days, 6 weeks.
Improvement in creatinine clearance.
Measured: 5 days
Improvement of hemodynamic parameters.
Measured: 5 days
Central venous oxygen saturation.
Measured: 1 day
Total mortality.
Measured: 6 months
Arrhythmias, hypotension, ischaemic episodes.
Measured: 5 days
Change in proBNP
Measured: Baseline to day 5
Change in clinical symptom score
Measured: Baseline to day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2011
- Study completionMar 2012
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 Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trygve Husebye, MD,, Principal investigator, Department of Cardiology, Ulleval University HospitalGeir Ø Andersen, MD, PhD, Study chair, Department of Cardiology, Ulleval University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324766
- Sponsor's protocol ID
- 0105
- Status last verified
- Jun 2012
- First submitted
- 10 May 2006
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Langseth MS, Andersen GO, Husebye T, Arnesen H, Zucknick M, Solheim S, Eritsland J, Seljeflot I, Opstad TB, Helseth R. Neutrophil extracellular trap components and myocardial recovery in post-ischemic acute heart failure. PLoS One. 2020 Oct 29;15(10):e0241333. doi: 10.1371/journal.pone.0241333. eCollection 2020.
PubMed 33119664Husebye T, Eritsland J, Arnesen H, Bjornerheim R, Mangschau A, Seljeflot I, Andersen GO. Association of interleukin 8 and myocardial recovery in patients with ST-elevation myocardial infarction complicated by acute heart failure. PLoS One. 2014 Nov 12;9(11):e112359. doi: 10.1371/journal.pone.0112359. eCollection 2014.
PubMed 25390695Husebye T, Eritsland J, Muller C, Sandvik L, Arnesen H, Seljeflot I, Mangschau A, Bjornerheim R, Andersen GO. Levosimendan in acute heart failure following primary percutaneous coronary intervention-treated acute ST-elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo-controlled study. Eur J Heart Fail. 2013 May;15(5):565-72. doi: 10.1093/eurjhf/hfs215. Epub 2013 Jan 2.
PubMed 23288914
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Levosimendan in Patients With Acute Myocardial Infarction Complicated by Symptomatic Left Ventricular Failure.
- ClinicalTrials.gov ID
- NCT00324766
- Acronym / sponsor ID
- 0105
- Conditions
- Myocardial Infarction, Heart Failure, Cardiogenic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 May 2006 (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 purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.
Detailed description
Double blind placebo-controlled study with parallel groups in patients with acute PCI treated myocardial infarction complicated with decompensated heart failure. The study include a prospectively defined subgroup of patients in cardiogenic shock. Treating acute myocardial infarction with PCI restores blood flow, but decreased contractility remains for hours and days due to stunned myocardium. Levosimendan has both inotropic and vasodilatory effects which could support the failing heart after treating the acute myocardial infarction with PCI and may improve myocardial stunning and decrease pro-inflammatory cytokines. Levosimendan could improve myocardial contractility, symptoms and outcome without adverse effects. The aims of the study are to investigate whether a 24 hour infusion with levosimendan could improve regional contractility measured by echocardiography, improve BNP levels, reduce the levels of pro-inflammatory cytokines and improve symptoms in patients with acute decompensated heart failure during the first 24 hours after acute PCI.
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 |
|---|---|---|
| 1 | Active comparator | Drug: levosimendanlevosimendan |
| 2 | Placebo comparator | Drug: placebo,Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
- Revascularization by PCI,
- Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
- Dyspnoea at rest and one of the following:
- pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.
Key exclusion criteria (10 listed)
- Age below 20 years
- Heart rate above 120 bpm
- Septic shock
- ARDS
- Creatinine >450 micromol/l
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: Simdax1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min | Drug | 1 |
| placebo,Also: placebo24 h, infusion | Drug | 2 |
Primary outcome
Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.
Time frame: At 5 days
Changes in regional contractility (WMSI) measured by echo is the primary endpoint in the study and the sample size calculation is based on expected differenced in WMSI from baseline to day 5 between groups.
11 secondary outcomes
Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.
Time frame: 6 months
Time to rehospitalisation for decompensated heart failure.
Time frame: 6 months
Days hospitalised/days in intensive/coronary care.
Time frame: At discharge
Changes in inflammation markers.
Time frame: 1, 5 days, 6 weeks.
Improvement in creatinine clearance.
Time frame: 5 days
Improvement of hemodynamic parameters.
Time frame: 5 days
Central venous oxygen saturation.
Time frame: 1 day
Total mortality.
Time frame: 6 months
Arrhythmias, hypotension, ischaemic episodes.
Time frame: 5 days
Change in proBNP
Time frame: Baseline to day 5
Change in clinical symptom score
Time frame: Baseline to day 5
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 26 Jun 2012.
- Derived from this study: PubMed 33119664Langseth MS, Andersen GO, Husebye T, Arnesen H, Zucknick M, Solheim S, Eritsland J, Seljeflot I, Opstad TB, Helseth R. Neutrophil extracellular trap components and myocardial recovery in post-ischemic acute heart failure. PLoS One. 2020 Oct 29;15(10):e0241333. doi: 10.1371/journal.pone.0241333. eCollection 2020.
- Derived from this study: PubMed 25390695Husebye T, Eritsland J, Arnesen H, Bjornerheim R, Mangschau A, Seljeflot I, Andersen GO. Association of interleukin 8 and myocardial recovery in patients with ST-elevation myocardial infarction complicated by acute heart failure. PLoS One. 2014 Nov 12;9(11):e112359. doi: 10.1371/journal.pone.0112359. eCollection 2014.
- Derived from this study: PubMed 23288914Husebye T, Eritsland J, Muller C, Sandvik L, Arnesen H, Seljeflot I, Mangschau A, Bjornerheim R, Andersen GO. Levosimendan in acute heart failure following primary percutaneous coronary intervention-treated acute ST-elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo-controlled study. Eur J Heart Fail. 2013 May;15(5):565-72. doi: 10.1093/eurjhf/hfs215. Epub 2013 Jan 2.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Trygve Husebye, MD, principal investigator
Department of Cardiology, Ulleval University Hospital
Geir Ø Andersen, MD, PhD study chair
Department of Cardiology, Ulleval 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 in people with Myocardial Infarction and Heart Failure, run by Oslo University Hospital at 1 site in Norway.
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 6 inclusion and 10 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 26 Jun 2012. 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 Norway. 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?
Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms. (time frame: At 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 NCT00324766, 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 26 Jun 2012.