Atrial FibrillationPhase 4NCT00189319
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation
A Phase 4 study of Atrial Fibrillation, run by MEDA Pharma GmbH & Co. KG at 1 site in France.
Trial summary
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2003to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In sinus rhythm at treatment initiation
- Experienced symptomatic AF episodes
- Left ventricular ejection fraction of at least 40%
- Females of child bearing potential must be using reliable method of contraception
Who cannot join
- Intolerance and/or failure of previous therapy with flecainide immediate release
- Currently receiving >200mg/day flecainide immediate release
- Severe symptoms during episodes of arrhythmia
- History of other cardiac conditions/abnormalities
- Heart surgery within the last 2 months
- Renal failure
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- Pregnant or lactating females
- Significant extra cardiac or systemic disease
- Abnormal electrolyte levels
- Receiving defined cardiac and/or other treatments
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Cardiologique, Service de Cardiologique CHR de Lille
Lille, 59037
About this study
Official title: Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
- Conditions
- Atrial Fibrillation
- Being tested
- Flecainide controlled release
- Keywords
- Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flecainide controlled releaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
Secondary outcomes (5)
assessment of treatment success based on an efficacy/safety composite criterion;
assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Salem Kacet, Principal investigator, Hopital Cardiologique, CHR de Lille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189319
- Sponsor's protocol ID
- 1478-FLEC
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 7 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00189319
- Acronym / sponsor ID
- 1478-FLEC
- Conditions
- Atrial Fibrillation
- Keywords
- Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In sinus rhythm at treatment initiation
- Experienced symptomatic AF episodes
- Left ventricular ejection fraction of at least 40%
- Females of child bearing potential must be using reliable method of contraception
Key exclusion criteria (10 listed)
- Intolerance and/or failure of previous therapy with flecainide immediate release
- Currently receiving >200mg/day flecainide immediate release
- Severe symptoms during episodes of arrhythmia
- History of other cardiac conditions/abnormalities
- Heart surgery within the last 2 months
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 |
|---|---|---|
| Flecainide controlled release | Drug | – |
Primary outcome
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).
5 secondary outcomes
assessment of treatment success based on an efficacy/safety composite criterion;
assessment of the relationship between QoL changes and outcomes related to safety and efficacy;
assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography;
assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination;
evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
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Atrial Fibrillation (AF)
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.
Salem Kacet principal investigator
Hopital Cardiologique, CHR de Lille, France
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 of Atrial Fibrillation, run by MEDA Pharma GmbH & Co. KG 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 4 inclusion and 10 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 7 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life).. 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 7 Feb 2022.