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ID
Source
Brief title
Health condition
Ankylosing spondylitis, osteoartritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diastolic dysfunction.
Diastolic dysfunction will be defined as follows: mild diastolic dysfunction (stage I—impaired relaxation). Characterized by an E/A ratio <1, Em/Am <1, prolonged DT (>240 ms), and IVRT (>110 ms). Em (<8 cm/s) is reduced. E/Em is <10. Moderate diastolic dysfunction (stage II— pseudo normalization). Characterized by an E/A ratio >1, Em/Am <1. Em (<8 cm/s) is reduced and E/Em is >10. Severe diastolic dysfunction (stage III— restrictive filling). This stage is characterized by an overt increased E/A ratio (>2), shortened DT (<150 ms), and IVRT (<60 ms). Em (<8 cm/s) remains at the lowest level. E/Em is >10. [13;20]
Secondary outcome
Systolic dysfunction: Systolic dysfunction will be defined as an ejection fraction of <50%.
Background summary
Background - The prevalence of cardiovascular disease in patients with ankylosing spondylitis (AS) is increased and results in increased mortality. The underlying pathogenic mechanism is associated to the general inflammatory process, which causes valvular heart disease, conduction disturbances and cardiomyopathy, as well as accelerated atherosclerotic disease. Studies investigating these cardiac and atherosclerotic diseases in AS that has been performed so far are contradictory and inconclusive regarding the current prevalences of these diseases.
Hypothesis - We hypothesize that the prevalence of cardiac disease such as valvular heart disease, conduction disturbances and decreased left ventricular function is higher in AS-patients compared with patients with osteoarthritis.
Study design – Cross sectional study
Objectives - Primary objective: To investigate left ventricular diastolic function in AS-patients compared with osteoarthritis patients.
Secondary objectives: To assess the prevalence of valvular heart diseases and conduction disturbances. To assess cIMT thickness. To assess left ventricular systolic function.
Methods - Physical examinations: Anthropometry and blood pressure measurement will be performed. The standard 12-lead electrocardiogram will be recorded and cIMT will be determined as measures of prevalent cardiovascular disease. Transthoracic echography will be performed by an echo technician.
Additional assessments: CRP (marker for low-grade inflammation), triglycerides, and total, LDL and HDL-cholesterol (markers for lipid metabolism) will be determined once in a fasting blood sample. B-type natiuretic peptide will be determined as a marker of heart failure. HLA-B27 will be determined as a predictor for AS. X-rays of chest, spine and pelvis will be performed once.
Questionnaires: smoking, alcohol intake, employment, education, marital status, current medication, disease history, family history of disease, extra spinal manifestations, patient’s global assessment of disease activity (VAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Global Score (BAS-G).
Study objective
We hypothesize that the prevalence of cardiac disease such as valvular heart disease, conduction disturbances and decreased left ventricular function is higher in AS-patients compared with patients with osteoarthritis.
Study design
baseline
Inclusion criteria
-AS according to New York (1984) criteria
-Written informed consent
-Age 50-75 years
Exclusion criteria
-Malignant disease
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7684 |
| CCMO | NL44202.048.13 |
| OMON | NL-OMON41462 |