Risk Profile for Patients With Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510210
Recruitment Status : Unknown
Verified May 2016 by I.C. Van Gelder, University Medical Center Groningen.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2012
Last Update Posted : May 11, 2016
Netherlands Heart Foundation
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Center Groningen

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.

Condition or disease
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.

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of a Risk Profile to Guide Atrial Fibrillation Therapy
Study Start Date : April 2011
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Success of rhythm control [ Time Frame: 12 month ]
    (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.

Secondary Outcome Measures :
  1. Time to recurrence of (a)symptomatic AF [ Time Frame: 1+3+6+9+12 month ]
    by assessment Percentage AF-burden on 24-holter during follow up

  2. Failure of rhythm control, i.e. permanent AF [ Time Frame: 1+3+6+9+12 month ]
    failure of rhythm control medication or electric cardioversion.

  3. Risk profiles associated with early versus late AF recurrence [ Time Frame: 1month and 12 month ]
    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

  4. Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF [ Time Frame: 1+3+6+9+12 month ]
    clinical commplaints and 3-lead Holter monitoring will be used for assessing the onset of AF episode

  5. Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1month and 12 month ]
    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

  6. Cardiovascular morbidity and mortality [ Time Frame: 1month and 12month ]
    hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.

  7. Pulmonary vein ablation [ Time Frame: 1month, 3month, 6month, 9 month, 12month ]
    hospital admission for pulmonary vein ablation will be monitoring during the study.

  8. Pathophysiological mechanisms associated with AF and success of rhythm control [ Time Frame: baseline-12 months ]
    To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF

Biospecimen Retention:   Samples With DNA
Serum and plasma stored at -80 degrees Celcius. If informed consent was obtained, DNA extraction has been performed.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with short-lasting symptomatic paroxysmal or persistent AF

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01510210

University Medical Center Groningen
Groningen, Netherlands, 9713 GZ Groningen
Sponsors and Collaborators
I.C. Van Gelder
Netherlands Heart Foundation
Principal Investigator: Harry Crijns, MD PhD Maastricht University Medical Center
Principal Investigator: Isabelle C Van Gelder, MD PhD University Medical Center Groningen

Responsible Party: I.C. Van Gelder, MD. PhD, University Medical Center Groningen Identifier: NCT01510210     History of Changes
Other Study ID Numbers: NHS2010B233
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by I.C. Van Gelder, University Medical Center Groningen:
Atrial Fibrillation
Rhythm control

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes