Effectiveness Study of Atrial Fibrillation (EFFECT-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by La-ser Europe Limited
Sponsor:
Information provided by (Responsible Party):
La-ser Europe Limited
ClinicalTrials.gov Identifier:
NCT01856075
First received: May 9, 2013
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Relative Effectiveness of Dronedarone vs. Other Treatments of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by La-ser Europe Limited:

Primary Outcome Measures:
  • Change from baseline Recurrence of Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: No ]
    Assessment of the recurrence of atrial fibrillation (change from baseline) at 3 month, 6 month, and 12-18 month of follow-up


Secondary Outcome Measures:
  • Change from baseline Cardiovascular hospitalisation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline AV node ablation and catheter ablation for Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: No ]
  • Change from baseline Progression to permanent Atrial Fibrillation [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Clinical progression to heart failure and left ventricular systolic dysfunction [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Congestive heart failure [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Interstitial pulmonary disease [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Liver injury/toxicity [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Renal insufficiency/failure [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Cerebrovascular accident/Stroke [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Myocardial infarction [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Change from baseline Torsade de pointes [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 3 month; 6 month; 12-18 month ] [ Designated as safety issue: Yes ]
    Assessed at each follow-up: 3 month, 6 month, and 12-18 month


Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856075

Locations
Germany
Praxis fuer Kardiologie, Im Muehlenbach 2B Recruiting
Bonn, Germany, 53127
Contact: Thomas Klingenheben, MD    0049 228 62 33 24    klingenheben@bonn-kardiologie.de   
Principal Investigator: Thomas Klingenheben, MD         
Sponsors and Collaborators
La-ser Europe Limited
Investigators
Study Director: Artak Khachatryan, PhD LA-SER Europe
  More Information

No publications provided

Responsible Party: La-ser Europe Limited
ClinicalTrials.gov Identifier: NCT01856075     History of Changes
Other Study ID Numbers: Sanofi-EFFECT-AF
Study First Received: May 9, 2013
Last Updated: May 16, 2013
Health Authority: United Kingdom: The European Medicines Agency's (EMA)
United Kingdom: Committee for Medicinal Products for Human Use (CHMP)

Keywords provided by La-ser Europe Limited:
Atrial Fibrillation
Dronedarone
Cohort
Effectiveness

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014