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

Heart Rate Variability in pre-clinical and clinical arthritis.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23052

Enrollment

100

Registered

2011-03-31

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RA reuma rheumatoid arthritis

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The 24-hour HRV will be analysed for day and night differences.	—

Contacts

Public ContactP.P. Tak

Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology, P.O. Box 22660

p.p.tak@amc.nl+31 (0)20 5662171

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)