Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arrhythmia Atrial Fibrillation Atrial Flutter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Amiodarone, long-term

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

Group Type EXPERIMENTAL

Fat tissue needle aspiration

Intervention Type PROCEDURE

Small fat tissue sampling performed by needle aspiration.

Interventions

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Fat tissue needle aspiration

Small fat tissue sampling performed by needle aspiration.

Intervention Type PROCEDURE

Other Intervention Names

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Adipose subcutaneous tissue biopsy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No