Acute Heart FailureLevoCorKidsNCT01704131
Levosimendan Pharmacokinetics in Children
An observational study of Acute Heart Failure, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Acute Heart Failure
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to 1 Sep 2019
- Phase
- Observational
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- All children admitted to the Pediatric Intensive Care Unit with Acute Heart Failure who will receive Levosimendan as part of their treatment.
Who cannot join
- no informed consent
- no sampling line
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
PICU Leiden University Medical Center
Leiden
Peter P Roeleveld, MD
About this study
Official title: Pharmacokinetics of Levosimendan in Children With Acute Heart Failure
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.
Read the 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.
- Conditions
- Acute Heart Failure
- Keywords
- Levosimendan, Children, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children > 6 months | children > 6 months of age | |
| children < 6 months | children < 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pharmacokinetic profile of levosimendan and is metabolites
AUC, Cmax, half-life, steady state concentration, plasma clearance, volume of distribution
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startNov 2012
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Peter Paul Roeleveld, Leiden University Medical Center
- Investigators
- Peter P Roeleveld, MD, Principal investigator, Leiden University Medical CenterHeleen E Bunker-Wiersma, MD, phd, Study chair, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704131
- Sponsor's protocol ID
- ICCE12.001
- Acronym
- LevoCorKids
- Status last verified
- Aug 2019
- First submitted
- 23 May 2012
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Levosimendan in Children With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT01704131
- Acronym / sponsor ID
- LevoCorKids / ICCE12.001
- Conditions
- Acute Heart Failure
- Keywords
- Levosimendan, Children, Pharmacokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Nov 2012 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 11 Oct 2012 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children > 6 months | – | –children > 6 months of age |
| children < 6 months | – | –children < 6 months |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All children admitted to the Pediatric Intensive Care Unit with Acute Heart Failure who will receive Levosimendan as part of their treatment.
Key exclusion criteria (2 listed)
- no informed consent
- no sampling line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the pharmacokinetic profile of levosimendan and is metabolites
Time frame: 3 years
AUC, Cmax, half-life, steady state concentration, plasma clearance, volume of distribution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
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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.
Peter P Roeleveld, MD principal investigator
Leiden University Medical Center
Heleen E Bunker-Wiersma, MD, phd study chair
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Aug 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter P Roeleveld, MD (+31715261677 ext. 8486, p.p.roeleveld@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pharmacokinetic profile of levosimendan and is metabolites (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2019.