Trials Sponsors Conditions Drugs Pricing

Conditions

Heart Rhythm Disorder

Keywords

heart rhythm disorderAmiodaroneCardiac arrhythmiasPediatricPopulation pharmacokinetic (Pop PK)Modeling

Outcome Measures

Primary Outcomes (5)

Maximal Concentration (Cmax) of amiodarone
Hour 0 to Hour 24
Area under the plasma concentration versus time curve (AUC) of amiodarone
Hour 0 to Hour 24
Clearance of amiodarone
Hour 0 to Hour 24
Volume of distribution of amiodarone
Hour 0 to Hour 24
Half time of amiodarone
Hour 0 to Hour 24

Secondary Outcomes (5)

Rhythm disorder
Day 0
Altered liver function
At the beginning of Amiodarone treatment until through study completion, an average of 18 months
Thyroid Dysfunction
At the beginning of Amiodarone treatment until through study completion, an average of 18 months
QT and corrected QT duration
At the beginning of Amiodarone treatment until through study completion, an average of 18 months
Blood pressure : (PAS)/(PAD) (mmHg)
At the beginning of Amiodarone treatment until through study completion, an average of 18 months

Study Arms (1)

Amiodarone dosage

EXPERIMENTAL

Blood pharmacokinetics samples

Other: Blood pharmacokinetic samples

Interventions

Blood pharmacokinetic samplesOther

1 or 3 sample(s) will be taken in the following time windows: \[H0-H3\]; \[H5-H9\] and just before the next set \[H24\], depending if the child is or is not admitted to hospital

Also known as: Amiodarone dosage

Amiodarone dosage

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

All children from 0 to 18 years old treated with Amiodarone for any rhythm disorder, and followed to Necker-Enfants maladies hospital.

You may not qualify if:

Sponsors & Collaborators

Assistance Publique - Hôpitaux de Paris
Otherlead
URC-CIC Paris Descartes Necker Cochin
Othercollaborator

Study Sites (1)

Necker Hospital

Paris, 75015, France

Related Publications (6)

Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.
PMID: 29435949BACKGROUND
Garson A Jr, Gillette PC, McVey P, Hesslein PS, Porter CJ, Angell LK, Kaldis LC, Hittner HM. Amiodarone treatment of critical arrhythmias in children and young adults. J Am Coll Cardiol. 1984 Oct;4(4):749-55. doi: 10.1016/s0735-1097(84)80402-7.
PMID: 6384328BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Jean-Marc TRELUYER, MD, PhD
Assistance Publique - Hôpitaux de Paris
STUDY DIRECTOR
Damien BONNET, MD, PhD
Assistance Publique - Hôpitaux de Paris
STUDY DIRECTOR
Sylvain RENOLLEAU, MD, PhD
Assistance Publique - Hôpitaux de Paris
STUDY DIRECTOR
Amelia LEHNERT, MD, PhD
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Enrollment

57 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 4, 2019

First Posted

February 15, 2019

Study Start

February 13, 2019

Actual (reported)

Pharmacokinetics of Amiodarone in Children

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (1)

Amiodarone dosage

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (5)

Study Arms (1)

Amiodarone dosage

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (6)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations