Risk Profile for Patients With Atrial Fibrillation

Sponsor
I.C. Van Gelder (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01510210
Collaborator
Netherlands Heart Foundation (Other)
500
1
179
2.8

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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
    Actual Study Start Date :
    Apr 1, 2011
    Anticipated Primary Completion Date :
    Mar 1, 2026
    Anticipated Study Completion Date :
    Mar 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Success of rhythm control [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 [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 [1+3+6+9+12 month]

      failure of rhythm control medication or electric cardioversion.

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

      hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.

    7. Pulmonary vein ablation [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 [baseline-12 months]

      To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands 9713 GZ Groningen

    Sponsors and Collaborators

    • I.C. Van Gelder
    • Netherlands Heart Foundation

    Investigators

    • Principal Investigator: Harry Crijns, MD PhD, Maastricht University Medical Center
    • Principal Investigator: Isabelle C Van Gelder, MD PhD, University Medical Center Groningen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    I.C. Van Gelder, MD. PhD, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT01510210
    Other Study ID Numbers:
    • NHS2010B233
    First Posted:
    Jan 16, 2012
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by I.C. Van Gelder, MD. PhD, University Medical Center Groningen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021