Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

Launched by FLINDERS UNIVERSITY · Aug 16, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating how the medication methotrexate affects blood pressure, the stiffness of arteries, and the overall health of blood vessels in people with rheumatoid arthritis. Rheumatoid arthritis is a chronic condition that causes inflammation in the joints and can also affect other parts of the body, including the heart and blood vessels. The researchers want to see if methotrexate, which is commonly used to treat rheumatoid arthritis, can help improve these aspects of cardiovascular health.

To participate in this study, you need to be at least 18 years old and diagnosed with rheumatoid arthritis based on specific criteria. Some individuals may not be eligible, such as those with certain heart conditions, severe hypertension, or other significant health issues. If you join the study, you will be monitored for about six months to see how methotrexate impacts your blood pressure and artery function. It's important to note that all participants will need to provide written consent before starting the study. This research could provide valuable information about the benefits of methotrexate beyond its effects on joint inflammation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria.
• • Age ≥18 years.
• • Written informed consent, dated and signed before initiating any study-related procedure.
• Exclusion Criteria:
• • Contraindication to MTX or sulfasalazine.
• • Patient who cannot be followed during 6 months.
• • Active alcohol or substance abuse within the last 12 months.
• • Participation in a clinical trial within 3 months prior to the start of the study.
• • Body mass index \>35 Kg/m2.
• • Secondary causes of hypertension.
• • Grade 2 (moderate) or 3 (severe) hypertension: clinic blood pressure \>160/100 mm Hg.
• • Resistant hypertension: clinical blood pressure ≥140/90 mm Hg despite concurrent use of three antihypertensive agents of different classes, one of which is a diuretic.
• • Clinical systolic blood pressure \<100 mm Hg or history of symptomatic orthostatic hypotension.
• • Cardiovascular event, procedure, or hospitalization for unstable angina with the last 6 months.
• • Atrial fibrillation.
• • Heart failure.
• • Treatment with nitrates.
• • Estimated glomerular filtration rate (eGFR) \<45 mL/min.
• • Diagnosis of polycystic kidney disease.
• • Glomerulonephritis treated with or likely to be treated with immunosuppressant drugs
• • Uncontrolled diabetes with HbA1c \>9.0% (\>75 mmol/mol).
• • Uncontrolled dyslipidaemia with total serum cholesterol \>7.5 mmol/L or triglycerides \>5.6 mmol/L.
• • Clinical diagnosis of dementia, treatment with medications for dementia or, in the opinion of the study staff, the participant is cognitively unable to follow the protocol.
• • Other medical, psychiatric, or behavioural factors that in the judgment of the study staff may interfere with study participation.
• • Cancer diagnosed and treated within the past 2 years that, in the judgment of the study staff, would compromise a participant's ability to comply with the protocol and complete the study.
• • Any organ transplant.
• • Pregnancy, currently trying to become pregnant, or of child bearing potential and not using birth control.
• • Significant illness within 2 weeks of study start.
• • Patients with an unstable active medical condition that could impair evaluation of study results.