Cardiovascular Diseases Clinical Trial
— POET-VEFOfficial title:
The Effect of Interruption of TNFi on Endothelial Function in Patients With Rheumatoid Arthritis
Verified date | April 2014 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Netherlands: Medical Ethics Review Committee (METC) |
Study type | Observational |
Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve endothelial function in patients with RA. Discontinuation of TNFi could therefore worsen endothelial function even in the absence of recurrence of systemic inflammation or reactivation of arthritis. If stopping TNFi results in worsening of endothelial function this would strongly suggest a higher cardiovascular risk in association with TNFi-wthdrawal
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Informed consent for POEET trial and this additional study - On stable medication (except for TNFi-therapy) Exclusion Criteria: - Uncontrolled hypertension (RR > 140/90 mmHg average of three measurements at screening after 5 minutes of supine rest) - Diabetes mellitus - Heart failure or any other cardiovascular disease that is expected to induce changes in cardiovascular medication during the study period. - Expected to start or change medication that can alter endothelial function (lipid lowering drugs, blood pressure lowering drugs, NSAIDs, immunosuppressive therapy other than TNFi drugs) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Radboud University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response to acetylcholine | The primary endpoint is the interaction between TNFi-withdrawal and the vasodilator response to acetylcholine expressed as difference in FBF between the withdrawal group and the continuing group. | 6 months | No |
Secondary | TNFi withdrawal and response to nitroprusside | Secondary endpoints are the interaction between TNFi-withdrawal and the vasodilator response to nitroprusside (expressed as difference in FBF between the withdrawal group and the continuing group). The response to SNP serves as an internal vasodilator control to assess potential endothelium-independent effects of TNFi-withdrawal on the response to acetylcholine. | 6 months | No |
Secondary | VCAM and SCAM | 6 months | No |
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