Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flinders University
• Collaborators: medac GmbH; University of South Australia
• Treatments: Methotrexate; Sulfasalazine

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.