The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

NCT ID: NCT05647577

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2033-03-01

Brief Summary

The goal of this prospective cohort study is to investigate cardiac comorbidity in a random sample of approximately 1200 patients from a population of outpatients with rheumatoid arthritis and axial spondyloarthritis referred to collectively as inflammatory arthritis (IA). The main questions it aims to answer are:

• Using conventional echocardiography, the investigators aim to determine the prevalence of overt and asymptomatic cardiac dysfunction in a large random sample of outpatients with IA. Cardiac dysfunction will be evaluated by echocardiography and cardiac biomarkers (NT-pro-BNP, hs-TNT and hs-CRP).
• In patients without known heart disease: Using 2, 5 and 10 year follow-up, the investigators aim to examine if advanced echocardiography can be used to detect early signs of heart disease by investigating the clinical significance of adding deformation measures - alone and in combination with selected biomarkers - to conventional risk factors in the cardiac risk assessment of patients with IA

Participants will undergo an echocardiographic examination in combination with a general health assessment including obtainment of cardiac biomarkers and a electrocardiogram.

Using advanced echocardiography - Tissue Doppler Imaging, 2- dimensional speckle tracking echocardiography, 3D-echocardiography and 3-dimensional speckle tracking echocardiography - the investigators also aim to compare myocardial deformation parameters of patients with IA to a gender and age matched control group without IA from the Copenhagen City Heart Study.

Conditions

Inflammatory Arthritis; Rheumatoid Arthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Spondyloarthritis; Heart Failure; Ischemic Heart Disease; Valvular Heart Disease; Left Ventricular Systolic Dysfunction; Heart Failure, Systolic; Heart Failure, Diastolic; Myocardial Infarction; Myocardial Dysfunction; Cardiac Disease; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inflammatory arthritis patients

Patients with an confirmed diagnosis of rheumatoid arthritis or axial spondyloarthritis.

No interventions assigned to this group

Participants from the general population

Patients with inflammatory arthritis will be compared to community-dwelling individuals from the 4th and 5th examination round from the Copenhagen City Heart Study (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Persons with a diagnosis of with a confirmed diagnosis of rheumatoid Arthritis or axial spondyloarthritis

Exclusion Criteria

• Persons not able to cooperate
• Persons unable understand and sign "informed consent"

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Tor Biering-Sørensen

Professor in Translational Cardiology and Pragmatic Randomized Trials

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

H-20023771

Identifier Type: -

Identifier Source: org_study_id