The objective of this study is to assess the risk profile which represents the degree of changes in the atrial tissue andwhich can help predict in which patients rhythm control will be successful. This risk profile will consist of a combination…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective:
To assess the risk profile associated with success of rhythm control therapy at
12 months of follow-up, i.e. all of the following: (1) < 1 second AF on ECG;
(2) < 30 seconds AF on 24 hour Holter recording and (3) no symptoms of AF.
Co- primary objective: To assess the risk profile associated with success of
rhythm control therapy at 60 months of follow-up, i.e. all of the following:
(1) < 1 second AF on ECG; (2) < 30 seconds AF on 24 hour Holter recording and
(3) no symptoms of AF.
Secondary outcome
1. To assess the risk profile associated with recurrence of (a)symptomatic AF;
2. To assess the risk profile associated with failure of rhythm control
therapy, i.e.
persistent or permanent AF after 1 year;
3. To assess the recurrence and/or progression of cardiac remodeling in AF
during follow-up
measured with use of echocardiography (atrial sizes, ventricular
function);
4. To study pathophysiological mechanisms of AF, e.g. collagen mediated,
inflammation mediated AF, or other mechanisms;
5. To assess the risk profile associated with early (< 4 weeks) versus late
(> after 4 weeks)
AF recurrences;
6. To relate risk profiles with cardiovascular morbidity and mortality;
7. To assess the risk profile associated with success of pulmonary vein
ablation;
8. To study differences in clinical outcome between patients presenting at
the emergency
room and outpatient department.
9. To assess differences in clinical characteristics (e.g. severity of
complaints, heart rate
during AF, ventricular function) between patients included in the
emergency department
versus the outpatient clinic.
10. To assess prognostic parameters predicting the occurrence of the combined
endpoint of
heart failure hospitalization or stroke or all-cause mortality in
patients with atrial fibrillation and heart failure.
11. To assess structural and functional changes by echocardiography in patients
with atrial fibrillation and heart
failure and AF.
Background summary
Atrial fibrillation is the most common arrhythmia: five to nine percent of
patients 60 years of age or older are affected.
Atrial fibrillation is responsible for a decreased exercise capacity due to a
fast heart rate and decreased cardiac function.
Atrial fibrillation can either be accepted (rate control), or treatment can
consist of restoration of normal sinus rhythm
(rhythm control). With regard to prognosis, rate control is not inferior to
rhythm control. However, in patients who remain
symptomatic, rhythm control remains therapy of choice. Rhythm control can be
achieved through antiarrhythmic
medication and/or electrical cardioversion. Nevertheless, despite rhythm
control, atrial fibrillation recurs in 50% to 80% of
patients within one year.
Atrial fibrillation is associated with a large number of known risk factors,
such as age or underlying (heart) disease such as
hypertension, cardiac ischemia, and diabetes, and less well-known risk factors
such as obesity and alcohol intake.
Important underlying mechanisms in atrial fibrillation consist of fibrosis and
inflammation, which occurs both in cardiac
atria and ventricles. Fibrosis and inflammation can be measured in the blood
through biomarkers. However, there is still much to be elucidated concerning
the measurement of these underlying mechanisms, the present study will add to
this knowledge.
Study objective
The objective of this study is to assess the risk profile 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. To achieve this patients will be
asked for bloodsamples which will be obtained during usual-care venepunctions
at inclusion, at 1 year and at 5 years of follow-up (no additonal
venepunctions will be performed). Furthermore patients will be asked for
permission to use their clinical information (e.g. echocardiographic
parameters) for this study.
Ultimately such a risk profile could be used to guide the type of rhythm
control therapy in individual patients with atrial fibrillation.
Study design
Single-center, prospective, observational study. Patients with symptomatic
paroxysmal or (long-standing) persistent atrial fibrillation (AF) in whom a
rhythm control strategy is preferred will be asked to participate. Clinical
factors, echocardiographic parameters, and blood samples for analysis of
circulating biomarkers will be collected. Patients presenting at the emergency
room will be compared to patients presenting at the outpatient clinical, not in
the setting of an emergency due to severity of complaints.
Study burden and risks
inclusionvisit:
- blood sample for analysis of biomarkers (to be combined with blood sampling
for usual care: no additional venepunctions will be performed)
1 year visit:
- blood sample for analysis of biomarkers (to be combined with blood sampling
for usual care: no additional venepunctions will be performed)
5 year visit:
- blood sample for analysis of biomarkers (to be combined with blood sampling
for usual care: no additional venepunctions will be performed)
These studyprocedures do not cause any specific risks for the participant.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Symptomatic paroxysmal or (long-standing) 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 > 10 years;
- Severe valvular disease;
- Acute coronary syndrome/ myocardial infarction/ percutaneous coronary intervention/ coronary artery bypass surgery within the past one month;
- Post-operative AF.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL38039.042.11 |