Risk Profile for 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: NCT01510197
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : July 28, 2015
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 (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.

Condition or disease
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.

Study Type : Observational
Actual Enrollment : 503 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of a Risk Profile in Patients With Atrial Fibrillation
Study Start Date : September 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. assess the risk profile associated with success of rhythm control therapy at follow-up. [ Time Frame: 12 months ]
    1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording

Secondary Outcome Measures :
  1. Time to recurrence of (a)symptomatic AF; [ Time Frame: 1+12+60 months ]
    by assessment Percentage AF-burden on 24-Holter during follow up

  2. Failure of rhythm control, i.e. permanent AF; [ Time Frame: 1+12+60 months ]
    <1 second AF on ECG during rhythm control medication or after electric cardioversion.

  3. Risk profiles associated with early versus late AF recurrence; [ Time Frame: 1+12+60 months ]
    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)

  4. Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF [ Time Frame: 1+12+60 months ]
    3-lead Holter monitoring will be used

  5. Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1+12+60 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: 1+12+60 months ]
    hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.

  7. Pulmonary vein ablation [ Time Frame: 1+12+60 months ]
    hospital admission for pulmonary vein ablation will be monitoring during the study.

  8. Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department [ Time Frame: Baseline,12+60 months ]
    collected parameters will be compared between these two groups.

  9. relate risk profiles to quality of life [ Time Frame: 1+12+60 months ]
    a quality of life questionnaire will be handed

  10. biomarkers associated with success of rhythm control [ Time Frame: baseline, 12 months, 60 months ]
    biomarker profiles (collagen mediated, inflammation, neurohumoral) associated with underlying mechanism of AF

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Ages Eligible for Study:   18 Years to 80 Years   (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): NCT01510197

University Medical center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
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: NCT01510197     History of Changes
Other Study ID Numbers: Biomarker
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

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