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Chronic damage in ANCA-associated vasculitis


- candidate number25059
- NTR NumberNTR6056
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-aug-2016
- Secondary IDsM016-025 METC NH
- Public TitleChronic damage in ANCA-associated vasculitis
- Scientific TitleSystemic damage and quality of life in patients with ANCA-associated vasculitis
- ACRONYMCD-AAV
- hypothesisWe hypothesize that cardiovascular disease and impaired quality of life are frequent long-term complications in AAV and often underdiagnosed.
- Healt Condition(s) or Problem(s) studiedANCA associated vasculitis, Chronic
- Inclusion criteriaIn order to participate in this study, a subject must meet all of the following criteria:
• Diagnosis GPA or MPA in accordance with the Chapel Hill Consensus Conference guidelines
• PR3 and/or MPO ANCA positive between 2005 and 2016
• Age ≥ 18 years
- Exclusion criteria- Secondary vasculitis due to rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome, connective tissue disease
- Drug induced vasculitis
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-sep-2016
- planned closingdate1-mrt-2021
- Target number of participants70
- InterventionsNo intervention planned. Data will be collected from routine patient visits, questionnaires and non-invasive measurements.
- Primary outcomeThe prevalence of chronic damage in ANCA-associated vasculitis, defined as:
- Prevalence of cardiovascular disease
- Impaired quality of life
- Depression
- Secondary outcome- The association between damage and disease activity
- The association between damage and survival
- TimepointsOne visit will be scheduled for all patients in which damage scores and disease activity scores will be calculated. Furthermore during this visit skin autofluoresence will be measured in all patients. Patients will fill out questionnaires on quality of life and depression in advance of the scheduled appointment.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Eline Houben
- CONTACT for SCIENTIFIC QUERIES Eline Houben
- Sponsor/Initiator Northwest Clinics
- Funding
(Source(s) of Monetary or Material Support)
Foreest instituut, Roche
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD12-aug-2016 - 3-nov-2016


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