Atrial FibrillationEFFECT-AFNCT01856075
Effectiveness Study of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by La-ser Europe Limited at 1 site in Germany.
Trial summary
This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,015 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Aug 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an international observational multicentre study to be conducted in the following four countries: Germany, Spain, Italy and USA. Patients will be will be recruited from cardiology clinics, both hospital and non-hospital based, depending on particulars of treatment pathway of ppAF patients in each country.
Who may be able to join
- Patient 18 years old or above
- Patient with paroxysmal or persistent atrial fibrillation
- Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
- Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
- Patient with at least 6 months of medical and treatment information prior to the start of the index drug
- Patient able to answer the telephone interview in a language of the participating country: English, German, Italian or Spanish (with or without proxy).
Who cannot join
- Patient with heart failure (NYHA class IV)
- Patient with permanent Atrial Fibrillation
- Patient with psychiatric conditions preventing the participation to the study according to the physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation
This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Dronedarone, Cohort, Effectiveness
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with dronedarone | Patients treated with dronedarone at inclusion | |
| Patients treated with other antiarrhythmic drugs of interest | The antiarrhythmic drugs of interest to which dronedarone will be compared are: * Class 1a/1c antiarrhythmics * Sotalol * Amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Recurrence of Atrial Fibrillation
Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up
Measured: 3 month; 6 month; 12-18 month
Secondary outcomes (12)
Change from baseline Cardiovascular hospitalisation
Measured: 3 month; 6 month; 12-18 month
Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation
Measured: 3 month; 6 month; 12-18 month
Change from baseline Progression to permanent Atrial Fibrillation
Measured: 3 month; 6 month; 12-18 month
Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction
Measured: 3 month; 6 month; 12-18 month
Change from baseline Congestive heart failure
Measured: 3 month; 6 month; 12-18 month
Change from baseline Interstitial pulmonary disease
Measured: 3 month; 6 month; 12-18 month
Change from baseline Liver injury/toxicity
Measured: 3 month; 6 month; 12-18 month
Change from baseline Renal insufficiency/failure
Measured: 3 month; 6 month; 12-18 month
Change from baseline Cerebrovascular accident/Stroke
Measured: 3 month; 6 month; 12-18 month
Change from baseline Myocardial infarction
Measured: 3 month; 6 month; 12-18 month
Change from baseline Torsade de pointes
Measured: 3 month; 6 month; 12-18 month
Death
Assessed at each follow-up: 3 month, 6 month, and 12-18 month
Measured: 3 month; 6 month; 12-18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2015
- Study completionAug 2015
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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- La-ser Europe Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artak Khachatryan, PhD, Study director, LA-SER Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856075
- Sponsor's protocol ID
- Sanofi-EFFECT-AF
- Acronym
- EFFECT-AF
- Status last verified
- Sep 2015
- First submitted
- 9 May 2013
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01856075
- Acronym / sponsor ID
- EFFECT-AF / Sanofi-EFFECT-AF
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Dronedarone, Cohort, Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- La-ser Europe LimitedUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 May 2013 (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.
This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest. The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with dronedarone | – | –Patients treated with dronedarone at inclusion |
| Patients treated with other antiarrhythmic drugs of interest | – | –The antiarrhythmic drugs of interest to which dronedarone will be compared are: * Class 1a/1c antiarrhythmics * Sotalol * Amiodarone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an international observational multicentre study to be conducted in the following four countries: Germany, Spain, Italy and USA. Patients will be will be recruited from cardiology clinics, both hospital and non-hospital based, depending on particulars of treatment pathway of ppAF patients in each country.
Key inclusion criteria (6 listed)
- Patient 18 years old or above
- Patient with paroxysmal or persistent atrial fibrillation
- Patient using an AAi (antiarrhythmic drug of interest) or dronedarone (index drug)
- Patient's treatment changed from one AAi to another AAi or dronedarone OR from no antiarrhythmic therapy to the start of AAi or dronedarone therapy during previous 6 months before the date of recruitment
- Patient with at least 6 months of medical and treatment information prior to the start of the index drug
Key exclusion criteria (3 listed)
- Patient with heart failure (NYHA class IV)
- Patient with permanent Atrial Fibrillation
- Patient with psychiatric conditions preventing the participation to the study according to the physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline Recurrence of Atrial Fibrillation
Time frame: 3 month; 6 month; 12-18 month
Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up
12 secondary outcomes
Change from baseline Cardiovascular hospitalisation
Time frame: 3 month; 6 month; 12-18 month
Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Progression to permanent Atrial Fibrillation
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Congestive heart failure
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Interstitial pulmonary disease
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Liver injury/toxicity
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Renal insufficiency/failure
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Cerebrovascular accident/Stroke
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Myocardial infarction
Time frame: 3 month; 6 month; 12-18 month
Change from baseline Torsade de pointes
Time frame: 3 month; 6 month; 12-18 month
Death
Time frame: 3 month; 6 month; 12-18 month
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 9 Sep 2015.
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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.
Artak Khachatryan, PhD study director
LA-SER Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by La-ser Europe Limited at 1 site in Germany.
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 6 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 9 Sep 2015. 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 Germany. 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.
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?
Change from baseline Recurrence of Atrial Fibrillation (time frame: 3 month; 6 month; 12-18 month). 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 9 Sep 2015.