Back to results

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

Primary Purpose

Arrhythmia, Atrial Fibrillation, Atrial Flutter

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Fat tissue needle aspiration

About this trial

This is an interventional diagnostic trial for Arrhythmia focused on measuring Anti-Arrhythmia Agents, Amiodarone, chronic treatment, Amiodarone, adverse effects, Biopsy, Fine-Needle, Adipose tissue, Drug concentrations in tissues, Drug accumulation in tissues

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amiodarone, long-term

Arm 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

Outcomes

Primary Outcome Measures

Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.

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

Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.

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

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

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

Secondary Outcome Measures

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

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

Presence of Any Adverse Effect Attributable to Amiodarone.

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

Full Information

NCT ID

NCT00313443

First Posted

April 10, 2006

Last Updated

July 6, 2011

Sponsor

Hopital Lariboisière

Collaborators

Unité de Recherches Therapeutiques - H. Lariboisiere

1. Study Identification

Unique Protocol Identification Number

NCT00313443

Brief Title

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

Acronym

ATACA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hopital Lariboisière

Collaborators

Unité de Recherches Therapeutiques - H. Lariboisiere

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmia, Atrial Fibrillation, Atrial Flutter

Keywords

Anti-Arrhythmia Agents, Amiodarone, chronic treatment, Amiodarone, adverse effects, Biopsy, Fine-Needle, Adipose tissue, Drug concentrations in tissues, Drug accumulation in tissues

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amiodarone, long-term

Arm Type

Experimental

Arm 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

Intervention Type

Procedure

Intervention Name(s)

Fat tissue needle aspiration

Other Intervention Name(s)

Adipose subcutaneous tissue biopsy

Intervention Description

Small fat tissue sampling performed by needle aspiration.

Primary Outcome Measure Information:

Title

Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose.

Description

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

Time Frame

One single measure

Title

Relationship Between Amiodarone Concentrations in Fat Tissue and in Plasma.

Description

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

Time Frame

One single measure, taken just before daily administration

Title

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

Description

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

Time Frame

Cumulated time on amiodarone (varies in each patient)

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

24 hours after needle aspiration

Title

Presence of Any Adverse Effect Attributable to Amiodarone.

Description

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

Time Frame

Cumulated time on amiodarone (varies in each patient)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmelo Lafuente-Lafuente, MD

Organizational Affiliation

Hopital Lariboisière, Internal Medicine "A" Service, Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-Francois Bergmann, MD

Organizational Affiliation

Hopital Lariboisiere, Internal Medicine "A" Service, Paris

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services

City

Paris

ZIP/Postal Code

75010

Country

France

12. IPD Sharing Statement

Learn more about this trial

Concentrations of Amiodarone in Fat Tissue During Chronic Treatment

We'll reach out to this number within 24 hrs