Risk Profile for Atrial Fibrillation

NCT ID: NCT01510197

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

I.C. Van Gelder

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabelle C van Gelder, Md PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical center Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

Other Identifiers

Biomarker

Identifier Type: -

Identifier Source: org_study_id