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Levosimendan Pharmacokinetics in Children (LevoCorKids)

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ClinicalTrials.gov Identifier: NCT01704131
Recruitment Status : Recruiting
First Posted : October 11, 2012
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Orion Corporation, Orion Pharma
Information provided by (Responsible Party):
Peter Paul Roeleveld, Leiden University Medical Center

Brief Summary:
Levosimendan is a drug used in patients with heart failure and has several advantages over other heart failure drugs. A lot of research has been done with Levosimendan in Adults, and the way the body handles the drug (pharmacokinetics) and responds to the drug (pharmacodynamics) are well established. But, in children this information is lacking despite the fact that Levosimendan is increasingly used in children of all ages. The investigators aim to describe which Levosimendan dose leads to which drug levels in children of different ages.

Condition or disease
Acute Heart Failure

Detailed Description:

Rationale: Levosimendan, a calcium-sensitizer, is a relatively new inotropic drug with the benefit over conventional inotropes that it does not increase myocardial oxygen demand or lead to arrhythmias. Levosimendan has a relatively unique pharmacokinetic profile, after a 24 hour infusion its clinical effects remain for several days. This is achieved through the continuing haemodynamic effects of its active metabolites, which have a half life of approximately 80 hours compared to 1 hour of Levosimendan itself. Levosimendan has been extensively studied in adults and is used in ischemic heart disease, acute heart failure, chronic heart failure, following cardiac surgery, and in septic shock. Due to the inotropic properties and its strong pulmonary vasodilatory effect, Levosimendan could also be very useful as perioperative therapy in children with congenital heart disease, low cardiac output, or pulmonary artery hypertension.

Although experience with levosimendan in children is still scarce in the literature, initial reports have been promising and Levosimendan is used more and more often as a (rescue) therapy in children with heart failure. However, current dosing regimens in children are based on adult pharmacokinetic evidence. One pediatric report suggests that the pharmacokinetic profile of a single loading dose of Levosimendan is probably similar in children older than 6 months compared to adults. The pharmacokinetic profile of a 24-hour infusion of Levosimendan has not yet been studied in children. It is very important to study the pharmacokinetics of this useful drug in different age groups because of the diversity of the population due to age, volume of distribution, ontogeny of the metabolizing enzymes, and the influence of disease state on pharmacokinetics and pharmacodynamics.

Objective: To describe the pharmacokinetic profile of a 24 hour infusion of levosimendan and its active metabolites in children with acute or chronic heart failure.

Study design: Observational study of Levosimendan levels in children treated with Levosimendan because of heart failure.

Study population: Children (< 16 years) admitted to the pediatric intensive care unit, with acute or chronic heart failure.

Intervention (if applicable): no intervention Main study parameters/endpoints: The primary endpoint of the study is to describe the pharmacokinetic profile by determining plasma levels of levosimendan and its metabolites during 12 days following a 24-hour infusion in children with heart failure in different age groups. Secondary endpoints are the clinically measured hemodynamic variables (heart rate, bloodpressure, lactate, troponin, pro-BNP, venous saturation) and echocardiographic variables (ejection fraction, shortening fraction, tissue Doppler) of all patients.


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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Levosimendan in Children With Acute Heart Failure
Actual Study Start Date : November 2012
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
children > 6 months
children > 6 months of age
children < 6 months
children < 6 months



Primary Outcome Measures :
  1. the pharmacokinetic profile of levosimendan and is metabolites [ Time Frame: 3 years ]
    AUC, Cmax, half-life, steady state concentration, plasma clearance, volume of distribution



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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All children admitted to the Pediatric Intensive Care Unit with Acute Heart Failure who will receive Levosimendan as part of their treatment.

Patients will receive Levosimendan whether they participate in the study (sampling levosimendan levels) or not.

Criteria

Inclusion Criteria:

  • All children admitted to the Pediatric Intensive Care Unit with Acute Heart Failure who will receive Levosimendan as part of their treatment.

Exclusion Criteria:

  • no informed consent
  • no sampling line

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704131


Contacts
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Contact: Peter P Roeleveld, MD +31715261677 ext 8486 p.p.roeleveld@lumc.nl
Contact: H E Bunker-Wiersma, MD, Phd +31715261677 ext 8775 H.E.Bunker-Wiersma@lumc.nl

Locations
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Netherlands
PICU Leiden University Medical Center Recruiting
Leiden, Netherlands
Principal Investigator: Peter P Roeleveld, MD         
Sponsors and Collaborators
Leiden University Medical Center
Orion Corporation, Orion Pharma
Investigators
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Principal Investigator: Peter P Roeleveld, MD Leiden University Medical Center
Study Chair: Heleen E Bunker-Wiersma, MD, phd Leiden University Medical Center

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Responsible Party: Peter Paul Roeleveld, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT01704131     History of Changes
Other Study ID Numbers: ICCE12.001
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Peter Paul Roeleveld, Leiden University Medical Center:
Levosimendan
Children
Pharmacokinetics
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Cardiotonic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs