Clinical trial NCT00313443: Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
Official title: Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Atrial Fibrillation
Atrial Flutter
Keywords: Anti-Arrhythmia Agents
Amiodarone, chronic treatment
Amiodarone, adverse effects
Biopsy, Fine-Needle, Adipose tissue
Drug concentrations in tissues
Drug accumulation in tissues
Lead sponsor: Hopital Lariboisière
Sponsor class: OTHER
Collaborators: name: Unité de Recherches Therapeutiques - H. Lariboisiere
First posted: 2006-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to determine if concentrations of amiodarone in fat tissue increases constantly over time during chronic treatment with this drug, and if blood concentrations reflect accurately the concentrations in fat tissue or not. This is because excessive concentrations of this drug in tissues can produce adverse effects.

Detailed description: Amiodarone is very effective to treat cardiac arrhythmias but its use is limited by its toxicity, specially in chronic treatment. Accumulation of the drug in tissues is very probably the cause of the majority of amiodarone delayed adverse effects. However, this has not been proved because obtaining tissue samples is usually difficult and aggressive.

The investigators study, in patients following chronic treatment with amiodarone, if needle aspiration can provide samples of fat tissue useful to accurately determine amiodarone concentrations, how those concentrations in fat tissue correlate with cumulated dose, and how concentrations in fat tissue correlate with concentrations in blood, which is easier to obtain.

The investigators expect this knowledge will help to understand how amiodarone develops its adverse effects and possibly lead to new ways of monitoring treatment with this drug, or to adapt doses in chronic administration.

Eligibility criteria: Inclusion Criteria:

* Adult patients taking amiodarone for more than 3 months (any dose, any indication)

Exclusion Criteria:

* Impossibility to perform needle aspiration of abdominal wall (local infection, skin disease)
* Coagulation disorders, INR \> 3.0 if warfarin treatment
* Patient unable to give informed consent

Primary outcomes:
measure: Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.
timeFrame: One single measure
measure: Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.
timeFrame: One single measure, taken just before daily administration
measure: Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.
timeFrame: Cumulated time on amiodarone (varies in each patient)
Secondary outcomes:
measure: Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations
timeFrame: 24 hours after needle aspiration
measure: Presence of Any Adverse Effect Attributable to Amiodarone.
timeFrame: Cumulated time on amiodarone (varies in each patient)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services
Study officials:
affiliation: Hopital Lariboisière, Internal Medicine "A" Service, Paris
name: Carmelo Lafuente-Lafuente, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Lariboisiere, Internal Medicine "A" Service, Paris
name: Jean-Francois Bergmann, MD
role: STUDY_DIRECTOR
References: