|- candidate number||9291|
|- NTR Number||NTR2833|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-mrt-2011|
|- Secondary IDs||10/327 MEC AMC|
|- Public Title||Veranderingen in het hartritme bij patiŽnten met reuma en bij mensen met een voorlopervorm van reuma (gekenmerkt door gewrichtsklachten en positieve reuma-antistoffen).|
|- Scientific Title||Heart Rate Variability in pre-clinical and clinical arthritis.|
|- hypothesis||Subjects with pre-clinical arthritis will have a lower HRV compared to healthy subjects and but still a higher HRV compare to active RA-patients. Follow-up of individuals with pre-clinical arthritis will give insight in the change of HRV over time in relation to the activity and thereby progression of arthritis.|
|- Healt Condition(s) or Problem(s) studied||Rheumatoid arthritis|
|- Inclusion criteria||1. 18-85 years;|
2. Individuals with pre-clinical arthritis (n=60):
A. Arthralgia and elevated ACPA level of > 25 IU/ml, or IgM-RF of > 49 IU/ml.
3. RA patients with active disease (n=20):
A. Has been diagnosed according to ACR criteria (Appendix 4: ACR -criteria);
B. Active arthritis in one or more joints at time of HRV-measurement.
4. Healthy subjects (n=20):
A. Negative for IgM-RF (level < 49 IU/ml) and ACPA (level of < 25 IU/ml).
|- Exclusion criteria||All subjects:|
1. Cardiovascular disease, such as ischaemic heart disease, cardiomyopathy, cardiac arrhythmia, cerebrovascular events, hypertension;
2. Neurological disorders, such as parkinsonism and multiple sclerosis;
3. Diabetes Mellitus and Hypercholesterolemia;
4. Medication influencing blood pressure or heart rate;
6. Nicotine use (smoking , nicotinegum or patch).
Individuals with Pre-clinical Arthritis:
1. Clinically evident arthritis;
2. Use of Disease Modifying Anti-Rheumatic Drugs (DMARDs);
3. Systemic or intra-articular corticosteroid injection less then 28 days before enrolment.
Active RA patients:
1. Use of TNF-blockers or anti-IL6 treatment.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-jan-2011|
|- planned closingdate||1-jul-2017|
|- Target number of participants||100|
|- Interventions||1. HRV will be measured in individuals with pre-clinical arthritis at three timepoints:|
A. Baseline: Subjects have been found to have arthralgias and a positive ACPA and/or IgM-RF;
B. Timepoint one: At first manifestation of arthritis, characterized by pain and swelling;
C. Timepoint two: Meets ACR criteria 1987 or 5 years after baseline.
2. HRV in Patients with active RA and healthy subjects will be measured at baseline only.
|- Primary outcome||HRV in subject with pre-clinical arthritis, patients with active RA and healthy subjects. HRV is a reflection of the autonomic nervous system and these results will be related to clinical presentation and physical examination of the subjects.|
|- Secondary outcome||The 24-hour HRV will be analysed for day and night differences.|
|- Timepoints||Subjects will be fitted with a Holter 24-hour electrocardiogram (ECG). Before the HRV-measurement patients will rest in supine position for approximately 20 minutes to stabilize the heart rate to get a reliable outcome. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. P.P. Tak|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. P.P. Tak|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Country of recruitment: The Netherlands.|
|- Main changes (audit trail)|
|- RECORD||31-mrt-2011 - 8-apr-2011|