The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

Active, not recruiting

• Conditions: Inflammatory Arthritis; Left Ventricular Systolic Dysfunction; Rheumatoid Arthritis; Spondyloarthritis; Heart Failure; Myocardial Infarction; Myocardial Dysfunction; Ischemic Heart Disease; Cardiac Disease; Stroke

• Registration Number: NCT05647577
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-03-01
• Study Completion: 2033-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1285

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"

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial infarction	10 years
Admission with congestive heart failure	10 years
Revascularization	10-year follow-up	Percutaneous coronary intervention or coronary artery bypass graft
Incident Heart Failure	10-year follow-up
Incident valvular disease	10-year follow-up
Cardiovascular mortality	10 year outcome

Trial Locations

Locations (1)

Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL); 🇩🇰 Hellerup, Denmark