The Relationship Between Inflammatory ARTritis and CArdiac DIseAse

NCT05647577 | Active Not Recruiting

• 1 other identifier: H-20023771
• Study Type: observational
• Target: 1,285
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (18)

• Cardiovascular mortality

  2-year follow-up

• Cardiovascular mortality

  5-year follow-up

• Cardiovascular mortality

  10 year outcome

• Admission with congestive heart failure

  2-year follow-up

• Admission with congestive heart failure

  5-year follow-up

• Admission with congestive heart failure

  10 years

• Myocardial infarction

  2-year follow-up

• Myocardial infarction

  5-year follow-up

• Myocardial infarction

  10 years

• Revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  2-year follow-up

• Revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  5-year follow-up

• Revascularization

  Percutaneous coronary intervention or coronary artery bypass graft

  10-year follow-up

• Incident Heart Failure

  2-year follow-up

• Incident Heart Failure

  5-year follow-up

• Incident Heart Failure

  10-year follow-up

• Incident valvular disease

  2-year follow-up

• Incident valvular disease

  5-year follow-up

• Incident valvular disease

  10-year follow-up

Study Arms (2)

Inflammatory arthritis patients

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

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

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

Hellerup, 2900, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and serum

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Axial Spondyloarthritis; Spondylarthritis; Heart Failure; Myocardial Ischemia; Heart Valve Diseases; Ventricular Dysfunction, Left; Heart Failure, Systolic; Heart Failure, Diastolic; Myocardial Infarction; Heart Diseases; Stroke

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Cardiovascular Diseases; Vascular Diseases; Ventricular Dysfunction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Translational Cardiology and Pragmatic Randomized Trials

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2021
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2033
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

DK (1)