Risk Profile for Patients With Atrial Fibrillation

November 28, 2023 updated by: I.C. Van Gelder

Identification of a Risk Profile to Guide Atrial Fibrillation Therapy

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ Groningen
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with short-lasting symptomatic paroxysmal or persistent AF

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of rhythm control
Time Frame: 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.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recurrence of (a)symptomatic AF
Time Frame: 1+3+6+9+12 month
by assessment Percentage AF-burden on 24-holter during follow up
1+3+6+9+12 month
Failure of rhythm control, i.e. permanent AF
Time Frame: 1+3+6+9+12 month
failure of rhythm control medication or electric cardioversion.
1+3+6+9+12 month
Risk profiles associated with early versus late AF recurrence
Time Frame: 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
1month and 12 month
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
Time Frame: 1+3+6+9+12 month
clinical commplaints and 3-lead Holter monitoring will be used for assessing the onset of AF episode
1+3+6+9+12 month
Changes in atrial and ventricular echocardiographic parameters
Time Frame: 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
1month and 12 month
Cardiovascular morbidity and mortality
Time Frame: 1month and 12month
hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.
1month and 12month
Pulmonary vein ablation
Time Frame: 1month, 3month, 6month, 9 month, 12month
hospital admission for pulmonary vein ablation will be monitoring during the study.
1month, 3month, 6month, 9 month, 12month
Pathophysiological mechanisms associated with AF and success of rhythm control
Time Frame: baseline-12 months
To study pathophysiological mechanisms of AF, e.g. collagen mediated or inflammation mediated AF
baseline-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.C. Van Gelder

Collaborators

Netherlands Heart Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 28, 2011

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimated)

January 16, 2012

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS2010B233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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