More on AF

Definition

RecordAF (REgistry on Cardiac rhythm disorders) is the first largest prospective international registry ever conducted in patients with paroxysmal or persistent atrial fibrillationⁱ (AF).The aim of the registry will be to evaluate the control of atrial fibrillation and clinical outcomes linked with AF treatment strategies over one year in hospital and office-based cardiologists

5,895 patients have been recruited from 21 countries in North and South America, Europe and Asia. Participating countries are: Austria, Belarus, Brazil, Colombia, Denmark, France, Germany, Greece, Hungary, Italy, Korea, Mexico, Philippines, Poland, Portugal, Russia, Spain, Sweden, Thailand, UK and U.S.

Recruitment began in May 2007 and was completed in April 2008. Final results are expected to be announced end 2009.

Baseline data from the RecordAF registry were presented during the Scientific Sessions of the American Heart Association Congress 2008 in New Orleans, USA. 

For more info, visit the RecordAF website: http://recordaf.org/

Aims and objectives

The RecordAF worldwide registry will provide valuable prospective data on the management of atrial fibrillation patients, global treatment algorithms and the success of individual treatment strategies.
RecordAF data will be invaluable for identifying best practice,in the management of AF. In order to accurately reflect clinical practice, the registry recruited patients recently diagnosed with AF (> 1 year) either treated with any type of anti-arrhythmic medication or untreated but eligible for a pharmacological treatment. Data were gathered at baseline, 6 and 12 months.

 

The primary objectives of RecordAF are to :

1) Assess the rate of therapeutic success of AF management at 12 months follow-up defined as:

Patients who remain in sinus rhythmⁱ or at rate controlⁱ target (<80bpm at rest) for the duration of the clinical trial
Patients who do not experience clinical outcomes such as cardiovascular death, strokeⁱ, myocardial infarction and hospitalisation for cardiovascular events
Patients not undergoing any crossover between rhythm or rate-control treatment strategies.

The secondary objectives are to :

2) Evaluate clinical outcomes in the two main strategies, rhythm controlⁱ and rate control

Gather information on the demographics of AF patients and treatment of AF patients managed by cardiologists worldwide
Understand prescribing behaviour (antiarrhythmic drugs, concomitant CV drugs, anticoagulants) in the AF setting
Correlate treatment choice with AF control and with clinical outcomes
Evaluate the use of antithrombotic and other medication
Evaluate health status and resource utilisation


Other assessments, conducted at 12 months follow-up, include:

Clinical outcomes in various pre-specified subgroups
Hospitalisations (all-cause and for and for cardiovascular disease)
Proportion of switches from rhythm-control to rate-control strategies and vice versa
Relationship between management of AF and health status/quality of life

Study Population and Design

Patients must be:
Male or female older than 18, diagnosed with AF for less than a year, treated or untreated, regardless of rhythm at inclusion.
Eligible for pharmacological treatment of AF by rhythm or rate-control agents

Patients who were excluded from RecordAF were:
Those with AF due to a transient cause or post cardiac surgery
Those with AF for less than three months
Patients with a pacemaker or Implantable Cardioverter Defibrillator (ICD)
Patients scheduled for pulmonary vein ablation, AV node/His bundle ablation, or pacemaker implantation
Patients included in a clinical trial in the field of AF in the previous three months
Pregnant or breastfeeding women

What Information will be gathered?

Data captured and measured include:
Demographics
History of AF including cardiovascular (CV) history, CV risk factors and electrical or pharmacological cardioversionⁱ
Weight, height, waist circumference, blood pressure, heart rateⁱ, biological data (if available)
Current drug therapy: Changes in AF therapy during the study, and the reason for the change
Adverse events related to current AF treatment
Cardiovascular outcomes
AF-related events during the study
Quality of life data including mobility, self-care, pain, anxiety / depression, duration and frequency of AF episodes, symptoms, exercise intolerance
Pharmacoeconomic data


RecordAF is supported by an educational grant from sanofi-aventis.