Concentrations of Amiodarone in Fat Tissue During Chronic Treatment (ATACA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00313443|
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : August 6, 2009
Last Update Posted : July 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Arrhythmia Atrial Fibrillation Atrial Flutter||Procedure: Fat tissue needle aspiration||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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
- 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)
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
|Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services|
|Paris, France, 75010|
|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|