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

July 6, 2011 updated by: Hopital Lariboisière

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Adipose subcutaneous tissue biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One single measure
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.
One single measure, taken just before daily administration
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.
Cumulated time on amiodarone (varies in each patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours after needle aspiration
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)
Cumulated time on amiodarone (varies in each patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Collaborators

Unité de Recherches Therapeutiques - H. Lariboisiere

Investigators

  • Principal Investigator: Carmelo Lafuente-Lafuente, MD, Hopital Lariboisiere, Internal Medicine "A" Service, Paris
  • Study Director: Jean-Francois Bergmann, MD, Hopital Lariboisiere, Internal Medicine "A" Service, Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATACA-URT04/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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