Cardiovascular Risk and Chronic Inflammatory Rheumatism

NCT03187444 | Active Not Recruiting

• 2 other identifiers: CHU-3372014-A01847-40
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic inflammatory rheumatism and inflammation can increase the risk of cardiovascular problems. Indeed, these diseases can increase the risk of myocardial infarction. The objective of this project is a better understanding and preventing the risk of cardiovascular problems in chronic inflammatory rheumatism through the study on the long-term flexibility of the arteries, blood markers of cardiovascular risk and muscle mass.

Conditions

Rheumatology; Cardiovascular Diseases; Arthritis, Rheumatoid; Spondyloarthritis

Keywords

Cardiovascular risk; Chronic inflammatory rheumatism; Rheumatoid arthritis; Spondyloarthritis; Inflammation

Outcome Measures

Primary Outcomes (16)

• Change from baseline of the arterial Stiffness

  evaluated by the pulse wave velocity

  at 6 months, 12 months

• Change from baseline of resting heart rate

  at 6 months, 12 months

• Change from baseline of endothelial function

  by Tonometry

  at 6 months, 12 months

• Change from baseline of intima-media thickness and carotid and femoral atheroma

  at 5 years

• Change from baseline of autonomic nervous system activity

  at 6 months, 12 months

• Change from baseline of regional myocardial function

  at 6 months, 12 months

• Change from baseline of other markers of cardiovascular risk

  troponin, NT\_proBNP, adipocytokines, MCP-1, assymetric dimethylaarginine, angiopoietin-2, anti apo A-1, IL-6, IL-17

  at 6 months, 12 months

• Change from baseline of an abdominal aortic calcification score (DEXA)

  at 6 months, 12 months

• Change from baseline of hand muscle strength (Handgrip)

  at 6 months, 12 months

• Change from baseline of energy expenditure and physical activity in usual living conditions

  by Android application on smartphone (eMeetingSearch)

  at 6 months, 12 months

• Change from baseline of food habits

  French FFQ questionnaire

  at 6 months, 12 months

• Change from baseline of body composition

  DEXA, pQCT

  at 6 months, 12 months

• Change from baseline of inflammatory rheumatism

  by the doctor in charge of the patient

  at 6 months, 12 months

• Change from baseline of depression (HAD)

  at 6 months, 12 months

• Change from baseline of fibromyalgia (FIRST)

  at 6 months, 12 months

• Change from baseline of the frequency of comorbidities during inflammatory rheumatism

  at 6 months, 12 months

Study Arms (1)

Patients with chronic inflammatory rheumatism

EXPERIMENTAL

All patients over 18 years, with rheumatoid arthritis treated for the first time with conventional anti-TNF therapy, Abatacept, Tocilizumab, Rituximab or patients with spondyloarthritis treated for the first time with NSAIDs that may be associated with conventional background treatments for peripheral or biological (anti-TNF, Usketinumab) may be included.

Procedure: Examinations

Interventions

Examinations PROCEDURE

Several examinations are realized on each patients, in addition to the usual visit and after verification of the criteria of inclusion and signature of consent.

Patients with chronic inflammatory rheumatism

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being older than 18 years
• Have rheumatoid arthritis or spondyloarthritis (ankylosing spondylitis, psoriatic arthritis)
• Receive first conventional DMARD or biological treatment (anti-TNF, Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis
• Receive biological treatment (Abatacept, Tocilizumab, rituximab) for patients with rheumatoid arthritis who have failed anti-TNF treatment.
• Receive first NSAID (optionally combined with conventional DMARDs in case of peripheral arthritis) or biological treatment (anti-TNF, Usketinumab) for patients with spondyloarthritis.
• Being subject to a social security scheme
• Have the capacity to give informed consent and to comply with the study requirements

You may not qualify if:

• Patient refused to sign the consent form
• Patient under guardianship
• Patient having already been exposed to a biological as part of its pathology
• Patient with chronic disease may interfere with cardiovascular disease either by itself or by treatment history
• For echocardiography high resolution STI: Patients with hypertension, diabetes and cardiovascular history.
• To evaluate the activity of the autonomic nervous system, patients with hypertension, diabetics, with cardiovascular history with a neurological disease, with vasoactive or chronotropic treatments such as beta-blockers, antiarrhythmics, antihypertensives, anxiolytics, antidepressants
• Pregnant or lactating women will be temporarily excluded from the study during the period of pregnancy and breastfeeding.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Arthritis, Rheumatoid; Spondylarthritis; Inflammation

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Martin SOUBRIER, PhD MD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: all participants receive the same intervention throughout the protocol

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 15, 2017
• Study Start: April 24, 2015
• Primary Completion (Estimated): October 24, 2036
• Study Completion (Estimated): April 4, 2037
• Last Updated: May 25, 2022

Record last verified: 2017-06

Locations

FR (1)