Clinical trial NCT01510197: Risk Profile for Atrial Fibrillation
Official title: Identification of a Risk Profile in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Arrhythmia
Rhythm control
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with short-lasting symptomatic paroxysmal or persistent AF

Brief summary: The objective of this study is to assess the risk profile in patients with atrial fibrillation, which represents the degree of changes (remodeling) in the atrial tissue and which can help to predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, as measured with use of parameters obtained with echocardiography, circulating biomarkers and other relevant clinical data. Ultimately this risk profile can be used to guide type of (rhythm) control therapy in individual patients with atrial fibrillation.

Detailed description: Atrial fibrillation is responsible for substantial morbidity and mortality.Identification of patients with AF that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size or volume could be a useful tool to select patients that will benefit from rhythm control therapy.Beside echocardiographic parameters,atrial fibrillation has been also associated with circulating biomarkers in blood like collagen metabolism, inflammatory mediators,neurohumoral factors and proteins/proteomic profiles. Beside more accepted risk factors (myocardial ischemia, diabetes and pulmonary disease)other less well-known clinical factors (sleep apnea, alcohol or other intoxication abuse, excessive physical activity, esophageal problems and increased body mass index) may also predict the outcome of rhythm control.It seems also plausible that recurrent atrial fibrillation within one month after start of rhythm control is associated with a different risk profile than late atrial fibrillation recurrences.During this study we will try to identify patients with atrial fibrillation who are more or less likely to respond to rhythm control therapy.

Eligibility criteria: Inclusion Criteria:

* Short-lasting symptomatic paroxysmal or persistent AF;
* Rhythm control strategy is preferred;
* No contra-indication for oral anticoagulation;
* Age \> 18 years;
* Written informed consent

Exclusion Criteria:

* Total history of heart failure and/ or of severe valvular disease \> 3 years;
* Severe valvular disease;
* Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
* Post-operative AF.

Primary outcomes:
measure: assess the risk profile associated with success of rhythm control therapy at follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Time to recurrence of (a)symptomatic AF;
timeFrame: 1+12+60 months
measure: Failure of rhythm control, i.e. permanent AF;
timeFrame: 1+12+60 months
measure: Risk profiles associated with early versus late AF recurrence;
timeFrame: 1+12+60 months
measure: Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
timeFrame: 1+12+60 months
measure: Changes in atrial and ventricular echocardiographic parameters
timeFrame: 1+12+60 month
measure: Cardiovascular morbidity and mortality
timeFrame: 1+12+60 months
measure: Pulmonary vein ablation
timeFrame: 1+12+60 months
measure: Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department
timeFrame: Baseline,12+60 months
measure: relate risk profiles to quality of life
timeFrame: 1+12+60 months
measure: biomarkers associated with success of rhythm control
timeFrame: baseline, 12 months, 60 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Isabelle C van Gelder, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: