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Sponsors and Collaborators: |
Hopital Lariboisière Unité de Recherches Therapeutiques - H. Lariboisiere |
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Information provided by: | Hopital Lariboisière |
ClinicalTrials.gov Identifier: | NCT00313443 |
The objective of this study is to determine if concentrations of amiodarone in fat tissue increase 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 | Intervention | Phase |
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Arrhythmia Atrial Fibrillation Atrial Flutter |
Procedure: Fat tissue needle aspiration |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment |
Enrollment: | 30 |
Study Start Date: | April 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
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Procedure: Fat tissue needle aspiration
Small fat tissue sampling performed by needle aspiration.
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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.
We 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.
We 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
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 |
Responsible Party: | Unité de Recherches Therapeutiques. Hopital Lariboisiere. ( Dr Carmelo Lafuente-Lafuente ) |
Study ID Numbers: | ATACA-URT04/06 |
Study First Received: | April 10, 2006 |
Last Updated: | January 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00313443 |
Health Authority: | France: Ministry of Health |
Anti-Arrhythmia Agents Amiodarone, chronic treatment Amiodarone, adverse effects |
Biopsy, Fine-Needle, Adipose tissue Drug concentrations in tissues Drug accumulation in tissues |
Heart Diseases Atrial Fibrillation Amiodarone Atrial Flutter Arrhythmias, Cardiac |
Vasodilator Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions |