Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

Condition(s) targeted: Arrhythmia; Atrial Fibrillation; Atrial Flutter

Intervention: Fat tissue needle aspiration (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Hopital Lariboisière

Official(s) and/or principal investigator(s):
Carmelo Lafuente-Lafuente, MD, Principal Investigator, Affiliation: Hopital Lariboisière, Internal Medicine "A" Service, Paris
Jean-Francois Bergmann, MD, Study Director, Affiliation: Hopital Lariboisiere, Internal Medicine "A" Service, Paris

The objective of this study is to determine if concentrations of amiodarone in fat tissue increase 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.

Official title: Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment

Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome:

Amiodarone concentration in fat tissue from several sampling points.

Amiodarone concentration in blood.

Total cumulated dose of amiodarone and cumulated time of treatment.

Secondary outcome:

Pain and complications (if any) caused by fat tissue needle aspirations

Presence of any adverse effect attributable to amiodarone.

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.

We 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.

We 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services, Paris 75010, France

Starting date: April 2006
Ending date: October 2007
Last updated: January 2, 2008