Clinical trial NCT05647577: The Relationship Between Inflammatory ARTritis and CArdiac DIseAse
Official title: Prevalence and Risk Factors Associated With Cardiac Comorbidity in Inflammatory Arthritis - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 1285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In order to approximate a random sample as accurate as possible, all patients with a diagnosis of rheumatoid Arthritis or axial spondyloarthritis followed in DANBIO in the capital region of Denmark will be eligible to participate. DANBIO is a nationwide registry of patients with rheumatoid Arthritis or axial spondyloarthritis and is approved as a clinical quality registry by the Danish National Board of Health in 2006.

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.


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"

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 2-year follow-up
measure: Cardiovascular mortality
timeFrame: 5-year follow-up
measure: Cardiovascular mortality
timeFrame: 10 year outcome
measure: Admission with congestive heart failure
timeFrame: 2-year follow-up
measure: Admission with congestive heart failure
timeFrame: 5-year follow-up
measure: Admission with congestive heart failure
timeFrame: 10 years
measure: Myocardial infarction
timeFrame: 2-year follow-up
measure: Myocardial infarction
timeFrame: 5-year follow-up
measure: Myocardial infarction
timeFrame: 10 years
measure: Revascularization
timeFrame: 2-year follow-up
measure: Revascularization
timeFrame: 5-year follow-up
measure: Revascularization
timeFrame: 10-year follow-up
measure: Incident Heart Failure
timeFrame: 2-year follow-up
measure: Incident Heart Failure
timeFrame: 5-year follow-up
measure: Incident Heart Failure
timeFrame: 10-year follow-up
measure: Incident valvular disease
timeFrame: 2-year follow-up
measure: Incident valvular disease
timeFrame: 5-year follow-up
measure: Incident valvular disease
timeFrame: 10-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Department of Cardiology | Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Cardiovascular Non-Invasive Imaging Research Laboratory (CIRL)
Study officials:
References: