Concentrations of Amiodarone in Fat Tissue During Chronic Treatment (ATACA)

Hopital Lariboisière

Status and phase: Completed; Phase 4

Conditions: Atrial Flutter; Atrial Fibrillation; Arrhythmia

Treatments: Procedure: Fat tissue needle aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT00313443

ATACA-URT04/06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Amiodarone, long-term

Experimental group

Description:

Unique arm: all patients were taking amiodarone for more than 6 months and all patietns underwent amiodarone dosage in blood and fat tissue samplings

Treatment:

Procedure: Fat tissue needle aspiration