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| Name | Class |
|---|---|
| Unité de Recherches Therapeutiques - H. Lariboisiere | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone, long-term | Experimental | Unique arm: all patients were taking amiodarone for more than 6 months and all patietns underwent amiodarone dosage in blood and fat tissue samplings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat tissue needle aspiration | Procedure | Small fat tissue sampling performed by needle aspiration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One single measure |
| 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. | One single measure, taken just before daily administration |
| 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. | Cumulated time on amiodarone (varies in each patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmelo Lafuente-Lafuente, MD | Hopital Lariboisière, Internal Medicine "A" Service, Paris | Principal Investigator |
| Jean-Francois Bergmann, MD | Hopital Lariboisiere, Internal Medicine "A" Service, Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services | Paris | 75010 | France |
67 consecutive patients were evaluated and 30 patients included. Reasons for non inclusion were: impossible to retrace history of amiodarone administration: 19 patients; less than 3 months on amiodarone treatment: 10 patients; unable to give informed consent: 4 patients; refused to participate: 4 patients.
Recruitment at a teaching hospital, from July 2006 to October 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Amiodarone/Fat Tissue Needle Aspiration | Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amiodarone/Fat Tissue Needle Aspiration | Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Correlation coefficient R | One single measure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amiodarone/Fat Tissue Needle Aspiration | Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local Complications (if Any) Caused by Fat Tissue Needle Aspirations | Skin and subcutaneous tissue disorders | Systematic Assessment |
Small number of patients included. High variability of amiodarone concentrations in fat tissue between the 2 simultaneous samples for some patients. Incidence of amiodarone-related adverse effects probably overestimated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Carmelo Lafuente-Lafuente | Unité de Recherches Thérapeutiques. Service de Médecine Interne A. Hôpital Lariboisière. Paris, France | +33 1 49 95 63 37 | c.lafuente@nodo3.net |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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) |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | 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. | Posted | Number | Correlation coefficient R | One single measure, taken just before daily administration |
|
|
|
| Primary | 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. | Posted | Number | Logistic regression OR | Cumulated time on amiodarone (varies in each patient) |
|
|
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| Secondary | Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations | Number of patients having complications (if any) caused by fat tissue needle aspirations | Posted | Number | Patients | 24 hours after needle aspiration |
|
|
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| Secondary | 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) | Posted | Number | Patients | Cumulated time on amiodarone (varies in each patient) |
|
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|
| 0 |
| 30 |
| 2 |
| 30 |
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