Risk Profile for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Identification of a Risk Profile in Patients With Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510197
• Other study ID #: Biomarker
• Status: Completed
• Phase: N/A
• First received: January 1, 2012
• Last updated: July 27, 2015
• Start date: September 2011
• Est. completion date: March 2015

Study information

• Verified date: July 2015
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Netherlands	University Medical center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	No
Secondary	Time to recurrence of (a)symptomatic AF;	by assessment Percentage AF-burden on 24-Holter during follow up	1+12+60 months	Yes
Secondary	Failure of rhythm control, i.e. permanent AF;	<1 second AF on ECG during rhythm control medication or after electric cardioversion.	1+12+60 months	Yes
Secondary	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)	1+12+60 months	Yes
Secondary	Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF	3-lead Holter monitoring will be used	1+12+60 months	Yes
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	1+12+60 month	Yes
Secondary	Cardiovascular morbidity and mortality	hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.	1+12+60 months	Yes
Secondary	Pulmonary vein ablation	hospital admission for pulmonary vein ablation will be monitoring during the study.	1+12+60 months	Yes
Secondary	Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department	collected parameters will be compared between these two groups.	Baseline,12+60 months	Yes
Secondary	relate risk profiles to quality of life	a quality of life questionnaire will be handed	1+12+60 months	Yes
Secondary	biomarkers associated with success of rhythm control	biomarker profiles (collagen mediated, inflammation, neurohumoral) associated with underlying mechanism of AF	baseline, 12 months, 60 months	No