Atrial FibrillationNCT01510197
Risk Profile for Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 503 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with short-lasting symptomatic paroxysmal or persistent AF
Who may be able to join
- Short-lasting symptomatic paroxysmal or persistent AF;
- Rhythm control strategy is preferred;
- No contra-indication for oral anticoagulation;
- Age > 18 years;
- Written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical center Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Identification of a Risk Profile in Patients With 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Arrhythmia, Rhythm control
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the risk profile associated with success of rhythm control therapy at follow-up.
- < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording
Measured: 12 months
Secondary outcomes (10)
Time to recurrence of (a)symptomatic AF;
by assessment Percentage AF-burden on 24-Holter during follow up
Measured: 1+12+60 months
Failure of rhythm control, i.e. permanent AF;
<1 second AF on ECG during rhythm control medication or after electric cardioversion.
Measured: 1+12+60 months
Risk profiles associated with early versus late AF recurrence;
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)
Measured: 1+12+60 months
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
3-lead Holter monitoring will be used
Measured: 1+12+60 months
Changes in atrial and ventricular echocardiographic parameters
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
Measured: 1+12+60 month
Cardiovascular morbidity and mortality
hospitalization for cardiovascular reasons, non-cardiovascular and cardiovascular death will be carefully monitored through-out the study.
Measured: 1+12+60 months
Pulmonary vein ablation
hospital admission for pulmonary vein ablation will be monitoring during the study.
Measured: 1+12+60 months
Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department
collected parameters will be compared between these two groups.
Measured: Baseline,12+60 months
relate risk profiles to quality of life
a quality of life questionnaire will be handed
Measured: 1+12+60 months
biomarkers associated with success of rhythm control
biomarker profiles (collagen mediated, inflammation, neurohumoral) associated with underlying mechanism of AF
Measured: baseline, 12 months, 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startSep 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I.C. Van Gelder, University Medical Center Groningen
- Investigators
- Isabelle C van Gelder, Md PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510197
- Sponsor's protocol ID
- Biomarker
- Status last verified
- Jul 2015
- First submitted
- 1 Jan 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of a Risk Profile in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01510197
- Acronym / sponsor ID
- Biomarker
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Arrhythmia, Rhythm control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with short-lasting symptomatic paroxysmal or persistent AF
Key inclusion criteria (5 listed)
- Short-lasting symptomatic paroxysmal or persistent AF;
- Rhythm control strategy is preferred;
- No contra-indication for oral anticoagulation;
- Age > 18 years;
- Written informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess the risk profile associated with success of rhythm control therapy at follow-up.
Time frame: 12 months
1) < 1 second AF on end-of-study ECG; (2) < 30 seconds AF on end-of-study 48-hour Holter recording
10 secondary outcomes
Time to recurrence of (a)symptomatic AF;
Time frame: 1+12+60 months
Failure of rhythm control, i.e. permanent AF;
Time frame: 1+12+60 months
Risk profiles associated with early versus late AF recurrence;
Time frame: 1+12+60 months
Progression of paroxysmal AF to persistent or permanent AF and of persistent AF to permanent AF
Time frame: 1+12+60 months
Changes in atrial and ventricular echocardiographic parameters
Time frame: 1+12+60 month
Cardiovascular morbidity and mortality
Time frame: 1+12+60 months
Pulmonary vein ablation
Time frame: 1+12+60 months
Differences in clinical profile and outcome between patients presenting at the emergency room and the outpatient department
Time frame: Baseline,12+60 months
relate risk profiles to quality of life
Time frame: 1+12+60 months
biomarkers associated with success of rhythm control
Time frame: baseline, 12 months, 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle C van Gelder, Md PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the risk profile associated with success of rhythm control therapy at follow-up. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.