Risk Profile for Patients With Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by University Medical Center Groningen
Netherlands Heart Foundation
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
First received: December 28, 2011
Last updated: July 27, 2015
Last verified: July 2015
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.

Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of a Risk Profile to Guide Atrial Fibrillation Therapy

Resource links provided by NLM:

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • Success of rhythm control [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    (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:
  • Time to recurrence of (a)symptomatic AF [ Time Frame: 1+3+6+9+12 month ] [ Designated as safety issue: Yes ]
    by assessment Percentage AF-burden on 24-holter during follow up

  • Failure of rhythm control, i.e. permanent AF [ Time Frame: 1+3+6+9+12 month ] [ Designated as safety issue: Yes ]
    failure of rhythm control medication or electric cardioversion.

  • Risk profiles associated with early versus late AF recurrence [ Time Frame: 1month and 12 month ] [ Designated as safety issue: Yes ]
    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

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

  • Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1month and 12 month ] [ Designated as safety issue: Yes ]
    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

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

  • Pulmonary vein ablation [ Time Frame: 1month, 3month, 6month, 9 month, 12month ] [ Designated as safety issue: Yes ]
    hospital admission for pulmonary vein ablation will be monitoring during the study.

  • Pathophysiological mechanisms associated with AF and success of rhythm control [ Time Frame: baseline-12 months ] [ Designated as safety issue: No ]
    To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF

Estimated Enrollment: 500
Study Start Date: April 2011
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510210

Contact: Isabelle van Gelder, MD PhD +31-(0)50-3611327 i.c.van.gelder@thorax.umcg.nl

University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ Groningen
Contact: Isabelle van Gelder, MD PhD    +31-050-3611327    i.c.van.gelder@umcg.nl   
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
  More Information

Responsible Party: I.C. Van Gelder, MD. PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01510210     History of Changes
Other Study ID Numbers: NHS2010B233 
Study First Received: December 28, 2011
Last Updated: July 27, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Center Groningen:
Atrial Fibrillation
Rhythm control

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

ClinicalTrials.gov processed this record on April 27, 2016