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Completed

NCT Number: NCT00313443

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

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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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services

Paris, 75010, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fat tissue needle aspiration

Procedure

Small fat tissue sampling performed by needle aspiration.

Other names: Adipose subcutaneous tissue biopsy

Primary outcomes

  1. Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.

    Time frame: One single measure

    Correlation between amiodarone concentration in fat tissue (mean from several sampling points) and cumulated dose.

  2. Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.

    Time frame: One single measure, taken just before daily administration

    Correlation between amiodarone concentrations in fat tissue (mean of 2 samples) and simultaneous concentration in plasma.

  3. Relationship Between Amiodarone Concentrations in Fat Tissue and Developing Adverse Effects.

    Time frame: Cumulated time on amiodarone (varies in each patient)

    Relationship between amiodarone concentrations in fat tissue (mean of two different samplings and developping adverse effects.

Secondary outcomes

  1. Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations

    Time frame: 24 hours after needle aspiration

    Number of patients having complications (if any) caused by fat tissue needle aspirations

  2. Presence of Any Adverse Effect Attributable to Amiodarone.

    Time frame: Cumulated time on amiodarone (varies in each patient)

    Number of patients developing adverse effects by amiodarone leading to withdrawal or specific treatment (i.e. thyroid hormone treatment)

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Collaborators

  • Unité de Recherches Therapeutiques - H. Lariboisiere

Registry information

Official study title

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

Acronym: ATACA

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2006
Registry last updated
Jul 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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