Impact of Hand Osteoarthritis on Arterial Stiffness

Osteoarthritis Clinical Trial

Official title:

Impact of Hand Osteoarthritis on Arterial Stiffness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167906
• Other study ID #: 9356
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: October 16, 2019

Study information

• Verified date: June 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 16, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• arterial stiffness measurement

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid-femoral arterial stiffness	To assess the carotid-femoral arterial stiffness determined by measuring the PWV in patients with hand OA compared to healthy subjects.	within the first 15 days after inclusion