Pharmacokinetics of Amiodarone in Children

NCT03842020 | Completed

• 2 other identifiers: APHP1802992018-A02327-48
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

PK-AMIO study is a population pharmacokinetic study of Amiodarone in children in order to :

• study the pharmacokinetic parameters (Pop PK) of Amiodarone in children;
• identify covariates explaining the variability of these pharmacokinetic parameters;
• study the relationship between the concentration, the efficacy of treatment and its tolerance to optimize the use of Amiodarone in pediatrics. Indeed, there is no consensus on the optimal oral dosage in children. Few pharmacokinetic studies have been performed with only a small number of patients per study. Our study will include 70 children aged 0 to 18 years old.

Conditions

Heart Rhythm Disorder

Keywords

heart rhythm disorder; Amiodarone; Cardiac arrhythmias; Pediatric; Population 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 samples OTHER

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

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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:

• Absence of parental and / or child consent
• Known liver dysfunction

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

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: 29435949 BACKGROUND

• 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: 6384328 BACKGROUND

• Coumel P, Fidelle J. Amiodarone in the treatment of cardiac arrhythmias in children: one hundred thirty-five cases. Am Heart J. 1980 Dec;100(6 Pt 2):1063-9. doi: 10.1016/0002-8703(80)90214-8.

  PMID: 7446409 BACKGROUND

• Bucknall CA, Keeton BR, Curry PV, Tynan MJ, Sutherland GR, Holt DW. Intravenous and oral amiodarone for arrhythmias in children. Br Heart J. 1986 Sep;56(3):278-84. doi: 10.1136/hrt.56.3.278.

  PMID: 3756044 BACKGROUND

• Pollak PT, Bouillon T, Shafer SL. Population pharmacokinetics of long-term oral amiodarone therapy. Clin Pharmacol Ther. 2000 Jun;67(6):642-52. doi: 10.1067/mcp.2000.107047.

  PMID: 10872646 BACKGROUND

• Lehnert A, Foissac F, Bouazza N, Urien S, Oualha M, Renolleau S, Barbanti C, Di Marzio A, Bonnet D, Abdalla S, Zheng Y, Treluyer JM. Amiodarone/N-desethylamiodarone population pharmacokinetics in paediatric patients. Br J Clin Pharmacol. 2022 Dec;88(12):5369-5377. doi: 10.1111/bcp.15458. Epub 2022 Jul 29.

  PMID: 35816412 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological 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

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
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)