No registrations found.
ID
Source
Health condition
RA
reuma
rheumatoid arthritis
Sponsors and support
Intervention
Outcome measures
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.
Background summary
Country of recruitment: The Netherlands.
Study objective
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.
Study design
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.
Intervention
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.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
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;
5. Pregnancy;
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.
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 |
|---|---|
| NTR-new | NL2304 |
| NTR-old | NTR2833 |
| Other | MEC AMC : 10/327 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |