Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis (NCT03254589) | Clinical Trial Compass
CompletedPhase 4
Methotrexate, Blood Pressure and Arterial Function in Rheumatoid Arthritis
Australia124 participantsStarted 2017-10-01
Plain-language summary
The investigators will study the effects of methotrexate on blood pressure, arterial stiffness and endothelial function in patients with rheumatoid arthritis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change in peripheral systolic blood pressure
Timeframe: Change from baseline peripheral systolic blood pressure at 6 months