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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41449   clinical trials with a EudraCT protocol, of which   6808   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2010-021263-33
    Sponsor's Protocol Code Number:3001101
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2010-021263-33
    A.3Full title of the trial
    PERIOPERATIVE LEVOSIMENDAN INFUSION IN PATIENTS WITH HEART FAILURE UNDERGOING NON-CARDIAC SURGERY: A PROSPECTIVE, RANDOMISED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER STUDY
    A.3.2Name or abbreviated title of the trial where available
    SIMPLE
    A.4.1Sponsor's protocol code number3001101
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSykehuset i Vestfold HF
    B.1.3.4CountryNorway
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Simdax
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma Espoo
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSimdax
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOSIMENDAN
    D.3.9.1CAS number 141505-33-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeinodilatator
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with serious cardiac failure scheduled for non-cardiac surgery
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10006387
    E.1.2Term Broken hip
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007559
    E.1.2Term Cardiac failure congestive
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007554
    E.1.2Term Cardiac failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066498
    E.1.2Term Cardiac failure chronic aggravated
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007558
    E.1.2Term Cardiac failure chronic
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024102
    E.1.2Term Left cardiac failure
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007561
    E.1.2Term Cardiac failure left
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007555
    E.1.2Term Cardiac failure (NOS)
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007564
    E.1.2Term Cardiac failure, congestive
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10007562
    E.1.2Term Cardiac failure NOS
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find differences between the 2 groups on cardiac outcomes. Does levosimendan given prophylactic perioperative, protect or enhance cardiac function compared to placebo?
    The primary endpoint is maximum change from baseline to postoperative NT-proBNP value. In addition, mean NT-proBNP response will be estimated over the time for each of the treament groups.
    E.2.2Secondary objectives of the trial
    We will also compare infusion with levosimendan vs. placebo for these parameters:

    Troponin T, hemodynamic parametres (CI, CO, SV, SVI) cardiovascular complications, use of inotrope/vasopressors, hospital- and ICU-stay, mortality after 30 days.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    1. Patients scheduled for acute or elective surgery (there must be time for at least 2 hours of infusion of the study medication prior to the start of surgery)
    2. The planned duration of the surgical procedure must be at least one (1) hour
    3. The acute surgery has to be either implantation of hemi- or total hip prosthesis
    4. The elective surgical procedure must be
    Abdominal aortic surgery
    Pheripheral surgery on arteries
    Carotide surgery (trombenartectomy)
    Intraabdominal and intrathoracal surgery
    Ortopedic surgery on spine.
    Implantation of hemi- or total prothesis - knee or hip.
    Radical prostatectomy, transurethral excluded.
    Cystectomy
    Hysterectomy
    Nephrectomy
    5. A) Preoperative echovariable test performed within last 12 months prior to inclusion: EF ≤ 35%. If an Acute myocardial infarction (AMI) last 12 months,the echocardiographic test must have been done > 1 months after an AMI or
    B) Known cardiac failure.
    6. NT-proBNP > 2000 pg/ml or 4000 pg/ml if renal failure (GFR<50)
    7. The patient has to use at least one of these medicaments:
    a. ACE- inhibitors
    b Angiotensin receptor blockers
    c. Diuretics
    d. Digoxin/Digitoxin
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. Patients under the age of 18
    2. Patients participating in another pharmaceutical study
    3. Known abuse of opioids, benzodiazepines, anti-epileptic drugs, α2-agonists or alcohol
    4. Pregnant or breastfeeding women. Women of childbearing age must have a negative pregnancy test.
    5. Acute myocardial infarction last month before admission
    6. Cardiac failure as a result of hypertrophic cardiomyopathy
    7. Verified severe aortic stenosis (aortic valve area < 1 cm2) or/and 50 mmHg (mean gradient)
    8. Persistent ventricular tachycardia
    9. History of torsades des pointes
    10. Persistent heart rate > 120/minute
    11. Systolic BP < 90 mmHg (non-invasive)
    12. S-potassium < 3 mmol/l (treated low s-pottasium to > 3 mmol/l is not an exclusion)
    13. Inability to give consent due to, e.g. dementia
    14. Hypersensitivity to levosimendan or its excipients
    15. Severe liver failure (known liver cirrhosis - Child-Pugh grade C)
    16. Severe renal failure (GFR < 30 ml/minute or creatinine > 200 mmol/l). Treated prerenal failure with GFR >30 ml/minute or creatinine < 200 mmol/l is not an exclusion.
    17. Prolonged QTc interval (men QTc > 0.43 s, women QTc > 0.45 s)
    18. Patient not expected to fullfill the study period according to anesthesiologist estimation
    19. Use of sulfonurea medication last 24 hours before inclusion
    20. Planned use of ketamine.

    E.5 End points
    E.5.1Primary end point(s)
    NT-proBNP will be measured preoperatively, thereafter 6, 24, 48, 72, 96, 120, 144, 168 hours after last stitch postoperatively (or only until the patient is discharged from hospital), up to a maximum of 168 hours postoperatively.
    The primary endpoint is maximum change from baseline to postoperative NT-proBNP value.

    In addition, mean NT-proBNP response will be estimated over the time for each of the treament groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6, 24, 48, 72, 96, 120, 144, 168 hours after last stitch postoperatively. Blood samples only if attendance at the hospital
    E.5.2Secondary end point(s)
    Troponin T - myocardial necrosis
    Ischemia (ECG)
    hemodynamic parametres (CI, CO, SV, SVI)
    cardiovascular complications
    use of inotrope/vasopressors
    hospital- and ICU-stay
    mortality after 30 days
    E.5.2.1Timepoint(s) of evaluation of this end point
    Troponin T - Daily during admission
    Ischemia (ECG) - continuous first 24 hours, after that 3rd, 5th and 7th day postoperatively
    hemodynamic parametres (CI, CO, SV, SVI) first 24 hours postoperatively
    cardiovascular complications - during admission + 30 day follow-up
    use of inotrope/vasopressors first 24 hours postoperatively
    hospital- and ICU-stay during admission
    mortality after 30 days - 30 days follow-up
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial is last visit 30 days after surgery. Subsequent if possible follow-up of mortality may optionally be carried out at 6 months and 1 year, using the records system.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No different treatment or care for the subjects after end of trial.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-03-08
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