ArrhythmiaPhase 4ATACANCT00313443
Concentrations of Amiodarone in Fat Tissue During Chronic Treatment
A Phase 4 study testing Fat tissue needle aspiration in people with Arrhythmia and Atrial Fibrillation, run by Hopital Lariboisière at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Fat tissue needle aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Oct 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients taking amiodarone for more than 3 months (any dose, any indication)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Lariboisiere, Internal Medicine "A" and Cardiology Services
Paris, 75010
About this study
Official title: 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.
Read the 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.
- Conditions
- Arrhythmia, Atrial Fibrillation, Atrial Flutter
- Being tested
- Fat tissue needle aspiration
- Keywords
- Anti-Arrhythmia Agents, Amiodarone, chronic treatment, Amiodarone, adverse effects, Biopsy, Fine-Needle, Adipose tissue, Drug concentrations in tissues, Drug accumulation in tissues
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat tissue needle aspirationProcedure or surgery
Also called Adipose subcutaneous tissue biopsy
Small fat tissue sampling performed by needle aspiration.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Fat tissue needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Cumulated time on amiodarone (varies in each patient)
Secondary outcomes (2)
Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations
Number of patients having complications (if any) caused by fat tissue needle aspirations
Measured: 24 hours after needle aspiration
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)
Measured: Cumulated time on amiodarone (varies in each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Collaborators
- Unité de Recherches Therapeutiques - H. Lariboisiere
- Investigators
- Carmelo Lafuente-Lafuente, MD, Principal investigator, Hopital Lariboisière, Internal Medicine "A" Service, ParisJean-Francois Bergmann, MD, Study director, Hopital Lariboisiere, Internal Medicine "A" Service, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313443
- Sponsor's protocol ID
- ATACA-URT04/06
- Acronym
- ATACA
- Status last verified
- Jun 2009
- First submitted
- 10 Apr 2006
- Last updated
- 14 Jul 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Concentrations of Amiodarone in Fat Tissue Obtained by Needle Aspiration in Patients on Chronic Treatment
- ClinicalTrials.gov ID
- NCT00313443
- Acronym / sponsor ID
- ATACA / ATACA-URT04/06
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Collaborators
- Unité de Recherches Therapeutiques - H. Lariboisiere
- Study start
- Apr 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Apr 2006 (estimated)
- Results
- Posted 6 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amiodarone, long-term | Experimental | Procedure: Fat tissue needle aspirationUnique arm: all patients were taking amiodarone for more than 6 months and all patietns underwent amiodarone dosage in blood and fat tissue samplings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients taking amiodarone for more than 3 months (any dose, any indication)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat tissue needle aspirationAlso: Adipose subcutaneous tissue biopsySmall fat tissue sampling performed by needle aspiration. | Procedure or surgery | Amiodarone, long-term |
Primary outcome
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.
2 secondary outcomes
Pain and Complications (if Any) Caused by Fat Tissue Needle Aspirations
Time frame: 24 hours after needle aspiration
Presence of Any Adverse Effect Attributable to Amiodarone.
Time frame: Cumulated time on amiodarone (varies in each patient)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo Lafuente-Lafuente, MD principal investigator
Hopital Lariboisière, Internal Medicine "A" Service, Paris
Jean-Francois Bergmann, MD study director
Hopital Lariboisiere, Internal Medicine "A" Service, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fat tissue needle aspiration in people with Arrhythmia and Atrial Fibrillation, run by Hopital Lariboisière at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Amiodarone Concentration in Fat Tissue and Cumulated Dose. (time frame: One single measure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2011.