Risk Profile for Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Identification of a Risk Profile to Guide Atrial Fibrillation Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01510210
• Other study ID #: NHS2010B233
• Status: Active, not recruiting
• Start date: April 2011
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
I.C. Van Gelder	Netherlands Heart Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of rhythm control	(1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording; (3) no AF on end-of-study 2 weeks Vitaphone ECG-card recording.	12 month
Secondary	Time to recurrence of (a)symptomatic AF	by assessment Percentage AF-burden on 24-holter during follow up	1+3+6+9+12 month
Secondary	Failure of rhythm control, i.e. permanent AF	failure of rhythm control medication or electric cardioversion.	1+3+6+9+12 month
Secondary	Risk profiles associated with early versus late AF recurrence	These parameters include underlying (heart) disease and risk factors (including age, family history for AF, signs of ischemia, coronary risk factors, pulmonary disease, diabetes, obesity, sleep apnea, esophageal problems), lifestyle (including caffeine and alcohol intake, exercise), autonomic trigger patterns of AF (i.e. vagal or adrenergic induced AF, or combination	1month and 12 month
Secondary	Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF	clinical commplaints and 3-lead Holter monitoring will be used for assessing the onset of AF episode	1+3+6+9+12 month
Secondary	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	1month and 12 month
Secondary	Cardiovascular morbidity and mortality	hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.	1month and 12month
Secondary	Pulmonary vein ablation	hospital admission for pulmonary vein ablation will be monitoring during the study.	1month, 3month, 6month, 9 month, 12month
Secondary	Pathophysiological mechanisms associated with AF and success of rhythm control	To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF	baseline-12 months