Primary objective: To compare at baseline the exact phenotypes of patients with young AF with versus without familial AF. Assessment of the phenotype includes clinical characteristics, presence of validated AF risk factors, (electro-)…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline the exact phenotypes of patients with young AF with versus without
familial AF. Assessment of the phenotype includes clinical characteristics,
presence of validated AF risk factors, (electro-)echocardiographic
abnormalities, presence of vascular abnormalities, endothelial dysfunction and
hypercoagulation.
Secondary outcome
I. At baseline differences in the prevalence of of 1) heart failure (systolic
and diastolic); 2) stroke, TIA and peripheral embolism; 3) coronary artery
disease including myocardial infarction, acute coronary syndrome and documented
significant coronary artery disease necessitating treatment; 4) diabetes
mellitus; 5) hypertension; 6) renal failure; 7) subclinical hyperthyroidism; 8)
obesity; 9) atrial remodeling measured as increase of atrial sizes and
reduction of atrial contractility; 10) biomarker profiles associated with
atrial remodeling including fibrosis inflammation, dedifferentiation, etc; 11)
biomarker profiles associated with vascular abnormalities, endothelial
dysfunction and hyperocagulation; 12) Genes associated with phenotypes of young
AF with or without a family history.
II. After 1 and 5 years of follow up differences between both groups in the
occurrence of 1) heart failure (systolic and diastolic); 2) stroke, TIA and
peripheral embolism; 3) coronary artery disease including myocardial
infarction, acute coronary syndrome and documented significant coronary artery
disease necessitating treatment; 4) diabetes mellitus; 5) hypertension; 6)renal
failure; 7) cardiovascular mortality; 8) bleeding; 9) severe adverse effects of
antiarrhythmic drugs; 10) atrial remodeling measured as increase of atrial
sizes and reduction of atrial contractility and remodeling as detected with use
of body surface mapping; 11) deterioration of left ventricular systolic and
diastolic function; 12) progression of AF to persistent or permanent AF; 13)
association of cardiovascular morbidity and mortality with atrial remodeling;
14) biomarker profiles associated with occurrence or deterioration of atrial
remodeling including fibrosis inflammation, dedifferentiation, etc; 15)
biomarker profiles associated with vascular abnormalities, endothelial
dysfunction and hypercoagulation; 16) Genes associated with progression of AF.
Background summary
Atrial fibrillation (AF) is the most common sustained arrhythmia and is
associated with significant morbidity and mortality including stroke and heart
failure and an impaired quality of life. AF mostly occurs in elderly patients
in the presence of underlying disease. In a minority AF may occur on a younger
age (< 60 years, *young onset AF*). Sometimes these patients have no detectable
mechanisms, i.e. AF occurs in the absence of validated risk factors. A subset
of young-onset AF patients has AF on a familial basis. The exact prevalence of
AF occurring at an age < 60 is unknown. In addition, it is not known which part
of these patients have familial AF. The exact phenotypes (i.e. clinical
characteristics) of young AF patients with and without familial AF have never
been investigated and is not known whether there are differences between both
groups of patients except for the family history. Assessing the exact
phenotypes of young AF patients including the presence or absence of familial
AF, may eventually improve risk stratification, therapeutic strategies and
outcome in the individual patient, enabling patient-tailored therapy.
Study objective
Primary objective: To compare at baseline the exact phenotypes of patients with
young AF with versus without familial AF. Assessment of the phenotype includes
clinical characteristics, presence of validated AF risk factors,
(electro-)echocardiographic abnormalities, presence of vascular abnormalities,
endothelial dysfunction and hypercoagulation.
Study design
This study is a single-center, prospective observational study. Consecutive
patients known at our AF clinic with AF onset at age < 60 years will be asked
to participate. Within this patient group phenotypical differences between
presence or absence of familial AF will be studied (e.g. prevalence of low-risk
AF). Matching of cases (familial AF) and controls (non-familial AF) will be
performed on age, type of AF, gender and total duration of AF on a 1:3 basis.
Detailed information on the family history, clinical risk factors for AF,
electro-echocardiography, body surface mapping, vascular and endothelial
function tests and blood samples for analysis of circulating biomarkers and
genetic markers will be collected during 3 visits to the outpatient clinic (at
inclusion and after 1 and 5 years of follow-up). The control group consists of
patients with AF without a family history.
Study burden and risks
Patients will be treated according to evidence-based standard care (ESC 2010 AF
guidelines). Visits to a research physician or research nurse will be performed
at inclusion, and after 1 and 5 years of follow-up. These visits will be
combined with routine visits to the outpatient clinic. Extra (study-related)
investigations consist of biomarker analyses, body surface mapping,
measurements of vascular function and additional measurements during
standard-care echocardiography. Participation to this study does not cause any
additonal risk.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
-AF onset at age < 60 years;
-Age > 18 years;
-Written informed consent.
Exclusion criteria
- Post-operative AF
- Myocardial infarction, acute coronary syndrome < 1 month before start AF
- AF triggered by acute infectious diseases
- Hyperthyroidism: patients have to be euthyroid for > 3 months before start 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 | NL40504.042.12 |