Risk Profile for Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University Medical Centre Groningen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01510197
First received: January 1, 2012
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of a Risk Profile in Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • assess the risk profile associated with success of rhythm control therapy at follow-up. [ Time Frame: 12 months ] [ 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


Secondary Outcome Measures:
  • Time to recurrence of (a)symptomatic AF; [ Time Frame: 1+12+60 months ] [ 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+12+60 months ] [ Designated as safety issue: Yes ]
    <1 second AF on ECG during rhythm control medication or after electric cardioversion.

  • Risk profiles associated with early versus late AF recurrence; [ Time Frame: 1+12+60 months ] [ Designated as safety issue: Yes ]
    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)

  • Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF [ Time Frame: 1+12+60 months ] [ Designated as safety issue: Yes ]
    3-lead Holter monitoring will be used

  • Changes in atrial and ventricular echocardiographic parameters [ Time Frame: 1+12+60 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: 1+12+60 months ] [ 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: 1+12+60 months ] [ Designated as safety issue: Yes ]
    hospital admission for pulmonary vein ablation will be monitoring during the study.

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

  • relate risk profiles to quality of life [ Time Frame: 1+12+60 months ] [ Designated as safety issue: Yes ]
    a quality of life questionnaire will be handed

  • biomarkers associated with success of rhythm control [ Time Frame: baseline, 12 months, 60 months ] [ Designated as safety issue: No ]
    biomarker profiles (collagen mediated, inflammation, neurohumoral) associated with underlying mechanism of AF


Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

Criteria

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: NCT01510197

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

Locations
Netherlands
University Medical center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Isabelle van Gelder, MD PhD    +31-050-3611327    i.c.van.gelder@umcg.nl   
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Isabelle C van Gelder, Md PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: I.C. Van Gelder, MD, PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01510197     History of Changes
Other Study ID Numbers: Biomarker
Study First Received: January 1, 2012
Last Updated: January 10, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
Atrial Fibrillation
Arrhythmia
Rhythm control

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

ClinicalTrials.gov processed this record on July 26, 2014