Risk Profile for Atrial Fibrillation

University Medical Center Groningen503 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

503

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical center Groningen

Groningen, Provincie Groningen, Netherlands

Outcomes

Primary Outcomes

assess the risk profile associated with success of rhythm control therapy at follow-up.

1\) \< 1 second AF on end-of-study ECG; (2) \< 30 seconds AF on end-of-study 48-hour Holter recording

Time frame: 12 months

Secondary Outcomes

Time to recurrence of (a)symptomatic AF;

by assessment Percentage AF-burden on 24-Holter during follow up

Time frame: 1+12+60 months

Failure of rhythm control, i.e. permanent AF;

\<1 second AF on ECG during rhythm control medication or after electric cardioversion.

Time frame: 1+12+60 months

Risk profiles associated with early versus late AF recurrence;

Parameters including underlying (heart) disease and risk factors (age, family history for AF, signs of ischemia, coronary risk factors, pulmonary disease, diabetes, obesity, sleep apnea, esophageal problems), lifestyle (caffeine and alcohol intake, exercise), autonomic trigger patterns of AF (i.e. vagal or adrenergic induced AF, or combination)

Time frame: 1+12+60 months

Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF

3-lead Holter monitoring will be used

Time frame: 1+12+60 months

Changes in atrial and ventricular echocardiographic parameters

Echocardiographic measures of LA size (LA size parasternal long axis view, LA volume,LA ejection fraction measurement, electro-echocardiographic parameters (Tissue Doppler total atrial conduction time (during sinus rhythm), AF cycle length and velocity (during AF)), and parameters of diastolic dysfunction, including E (early mitral valve flow velocity), A (late mitral valve flow velocity), E/A ratio, deceleration time, E' (early tissue Doppler lengthening velocity), and E/E' ratio

Data from ClinicalTrials.gov

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