Impact of Hand Osteoarthritis on Arterial Stiffness

University Hospital Center (CHU)

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: arterial stiffness measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02167906

9356

Details and patient eligibility

About

Patients affected by osteoarthritis (OA) have an increase overall mortality compared to the general population, mainly due to cardiovascular diseases. OA patients without cardiovascular risk have a 10 years cardiovascular events higher of around 15-30 %. Although the molecular mechanisms are still not well known, the structure and function of the vessel wall can be affected by several inflammatory and metabolic parameters during OA.These functional and structural changes of the arterial wall leads to arterial stiffness, measured by the pulse-wave velocity (PWV). PWV is the most widely used technique to assess arterial stiffness and has been shown to have predictive value for morbidity and mortality. In our study, we planned to compare arterial stiffness in OA patients with healthy subjects.

Enrollment: 80 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with clinical hand OA defined according to the ACR (American College of Rheumatology) criteria.
• Patients with radiographic hand OA defined according to the Kellgren
• Lawrence criteria (≥ 2).
• Steady dose of statins for at least one month.
• Subject affiliated to a social security scheme
• Written informed consent

Exclusion criteria

• Rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis diseases.
• History of arterial hypertension treated and / or uncontrolled (SBP > 140 mmHg and DBP (diastolic blood pressure) > 90 mmHg)
• Diabetes (fasting blood glucose > 7 mmol/L)
• Obesity (BMI > 35 kg/m²)
• Chronic renal failure defined by a glomerular filtration rate <60 ml/min/1,73m ².
• Patient with uncontrolled cardiovascular disease or a personal history of cardiovascular events (myocardial infarction and angina, occlusive arterial disease, stroke)
• Pregnant or breastfeeding, or premenopausal and not taking an effective contraception

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

hand oa patients

Experimental group

Description:

assess the carotid-femoral arterial stiffness determined by measuring the PWV

Treatment:

Other: arterial stiffness measurement

without Hand OA patients

Active Comparator group

Description:

assess the carotid-femoral arterial stiffness determined by measuring the PWV

Treatment:

Other: arterial stiffness measurement