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Completed

NCT Number: NCT01510197

Risk Profile for Atrial Fibrillation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical center Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. assess the risk profile associated with success of rhythm control therapy at follow-up.

    Time frame: 12 months

    • < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

Identification of a Risk Profile in Patients With Atrial Fibrillation

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2012
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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