Clinical trial NCT01510210: Risk Profile for Patients With Atrial Fibrillation
Official title: Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Arrhythmia
Rhythm control
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Netherlands Heart Foundation
First posted: 2012-01-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
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 in the atrial tissue and which can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination of underlying (heart) disease and risk factors, measurements obtained from echocardiograms, and circulating biomarkers. 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 atrial fibrillation that is difficult to treat may improve the outcome of rhythm control therapy. Left atrial size 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 likes also plausible that recurrent atrial fibrillation within one month after start of rhythm control are associated with a different risk profile than late atrial fibrillation recurrence.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: Success of rhythm control
timeFrame: 12 month
Secondary outcomes:
measure: Time to recurrence of (a)symptomatic AF
timeFrame: 1+3+6+9+12 month
measure: Failure of rhythm control, i.e. permanent AF
timeFrame: 1+3+6+9+12 month
measure: Risk profiles associated with early versus late AF recurrence
timeFrame: 1month and 12 month
measure: Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
timeFrame: 1+3+6+9+12 month
measure: Changes in atrial and ventricular echocardiographic parameters
timeFrame: 1month and 12 month
measure: Cardiovascular morbidity and mortality
timeFrame: 1month and 12month
measure: Pulmonary vein ablation
timeFrame: 1month, 3month, 6month, 9 month, 12month
measure: Pathophysiological mechanisms associated with AF and success of rhythm control
timeFrame: baseline-12 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: Maastricht University Medical Center
name: Harry Crijns, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Isabelle C Van Gelder, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De With RR, Artola Arita V, Nguyen BO, Linz D, Ten Cate H, Spronk H, Schotten U, Jan van Zonneveld A, Erkuner O, Bayon MA, Schmidt AS, Luermans JGLM, Crijns HJGM, Van Gelder IC, Rienstra M. Different circulating biomarkers in women and men with paroxysmal atrial fibrillation: results from the AF-RISK and RACE V studies. Europace. 2022 Feb 2;24(2):193-201. doi: 10.1093/europace/euab179.
citation: Nguyen BO, Meems LMG, van Faassen M, Crijns HJGM, van Gelder IC, Kuipers F, Rienstra M. Gut-microbe derived TMAO and its association with more progressed forms of AF: Results from the AF-RISK study. Int J Cardiol Heart Vasc. 2021 May 24;34:100798. doi: 10.1016/j.ijcha.2021.100798. eCollection 2021 Jun.
citation: De With RR, Marcos EG, Dudink EAMP, Spronk HM, Crijns HJGM, Rienstra M, Van Gelder IC. Atrial fibrillation progression risk factors and associated cardiovascular outcome in well-phenotyped patients: data from the AF-RISK study. Europace. 2020 Mar 1;22(3):352-360. doi: 10.1093/europace/euz339.