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

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ClinicalTrials.gov Identifier: NCT00313443
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : August 6, 2009
Last Update Posted : July 14, 2011
Sponsor:
Collaborator:
Unité de Recherches Therapeutiques - H. Lariboisiere
Information provided by:
Hopital Lariboisière

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.

Condition or disease Intervention/treatment Phase
Arrhythmia Atrial Fibrillation Atrial Flutter Procedure: Fat tissue needle aspiration Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
Study Start Date : April 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Arm Intervention/treatment
Experimental: 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
Procedure: Fat tissue needle aspiration
Small fat tissue sampling performed by needle aspiration.
Other Name: Adipose subcutaneous tissue biopsy




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313443


Locations
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France
Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services
Paris, France, 75010
Sponsors and Collaborators
Hopital Lariboisière
Unité de Recherches Therapeutiques - H. Lariboisiere
Investigators
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Principal Investigator: Carmelo Lafuente-Lafuente, MD Hopital Lariboisière, Internal Medicine "A" Service, Paris
Study Director: Jean-Francois Bergmann, MD Hopital Lariboisiere, Internal Medicine "A" Service, Paris

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Responsible Party: Dr Carmelo Lafuente-Lafuente, Unité de Recherches Therapeutiques. Hopital Lariboisiere.
ClinicalTrials.gov Identifier: NCT00313443     History of Changes
Other Study ID Numbers: ATACA-URT04/06
First Posted: April 12, 2006    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: July 14, 2011
Last Verified: June 2009

Keywords provided by Hopital Lariboisière:
Anti-Arrhythmia Agents
Amiodarone, chronic treatment
Amiodarone, adverse effects
Biopsy, Fine-Needle, Adipose tissue
Drug concentrations in tissues
Drug accumulation in tissues

Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors