search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Veranderingen in het hartritme bij patiŽnten met reuma en bij mensen met een voorlopervorm van reuma (gekenmerkt door gewrichtsklachten en positieve reuma-antistoffen).


- candidate number9291
- NTR NumberNTR2833
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2011
- Secondary IDs10/327 MEC AMC
- Public TitleVeranderingen in het hartritme bij patiŽnten met reuma en bij mensen met een voorlopervorm van reuma (gekenmerkt door gewrichtsklachten en positieve reuma-antistoffen).
- Scientific TitleHeart Rate Variability in pre-clinical and clinical arthritis.
- ACRONYM
- hypothesisSubjects 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) studiedRheumatoid arthritis
- Inclusion criteria1. 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 criteriaAll 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jan-2011
- planned closingdate1-jul-2017
- Target number of participants100
- Interventions1. 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 outcomeHRV 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 outcomeThe 24-hour HRV will be analysed for day and night differences.
- TimepointsSubjects 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 siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P.P. Tak
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryCountry of recruitment: The Netherlands.
- Main changes (audit trail)
- RECORD31-mrt-2011 - 8-apr-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl