NCT01704131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

6.8 years

First QC Date

May 23, 2012

Last Update Submit

August 19, 2019

Conditions

Acute Heart Failure

Keywords

LevosimendanChildrenPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • the pharmacokinetic profile of levosimendan and is metabolites

    AUC, Cmax, half-life, steady state concentration, plasma clearance, volume of distribution

    3 years

Study Arms (2)

children > 6 months

children \> 6 months of age

children < 6 months

children \< 6 months

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • no informed consent
  • no sampling line

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PICU Leiden University Medical Center

Leiden, Netherlands

RECRUITING

Study Officials

  • Peter P Roeleveld, MD

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

  • Heleen E Bunker-Wiersma, MD, phd

    Leiden University Medical Center

    STUDY CHAIR

Central Study Contacts

Peter P Roeleveld, MD

CONTACT

+31715261677p.p.roeleveld@lumc.nl

H E Bunker-Wiersma, MD, Phd

CONTACT

+31715261677H.E.Bunker-Wiersma@lumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2012

First Posted

October 11, 2012

Study Start

November 1, 2012

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations

NL(1)