The effect of JAnus KinAse inhibitors on the heart in RheumaToid Arthritis

The effect of JAnus KinAse inhibitors on the heart in RheumaToid Arthritis - JAKARTA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51028

Enrollment

105

Registered

2021-11-16

Start date

2022-03-07

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

arthritis joint disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of rheumatoid arthritis according to the ACR/EULAR 2010 criteria - Moderate to high disease activity defined as a Disease Activity Score 28 (DAS28) >=3.2 - Clinical indication for treatment with a JAK inhibitor - No changes to pharmacological therapy in last 4 weeks - Age 18-70 years

Exclusion criteria

Exclusion criteria: - Symptoms of angina or heart failure - Left main stenosis >50% on CCTA - History of hypertension, dyslipidaemia, diabetes mellitus, myocardial infarction, coronary revascularization, cardiac transplantation, pacemaker or implantable cardioverter defibrillator implantation, valvular disease, heart failure, second or third degree heart block, (supra)ventricular tachycardia or frequent premature atrial or ventricular complexes. - Contraindications to intravenous adenosine administration (e.g. Chronic Obstructive Pulmonary Disease stage IV) or asthma, systemic hypotension with mean arterial blood pressure

Design outcomes

Primary

Measure	Time frame
The main study parameter is the change in left ventricular function in rheumatoid arthritis patients after 1 year of treatment with a JAK inhibitor. Left ventricular function will be assessed at baseline and follow-up using cardiac magnetic resonance measurements of global circumferential, longitudinal and radial strain.	—

Secondary

Measure	Time frame
Secondary endpoints are grouped into 2 categories. The first category consists of comparisons between baseline and follow-up data in rheumatoid arthritis patients treated with a JAK inhibitor for 1 year. The second category consists of comparisons between rheumatoid arthritis patients and age-matched healthy volunteers. For both categories, secondary endpoints included differences in: - coronary atherosclerosis as asssed with CCTA - myocardial inflammation, myocardial perfusion and myocardial fibrosis as assesed with CMR In addition, secondary endpoints will also include clinical treatment response in the patients with rheumatoid arthritis, assessed using the American College of Rheumatology response rate, DAS-28 score and biomarkers such as C-reactive protein and erythrocyte sedimentation rate.	—

Measure

Time frame

Secondary endpoints are grouped into 2 categories. The first category consists of comparisons between baseline and follow-up data in rheumatoid arthritis patients treated with a JAK inhibitor for 1 year. The second category consists of comparisons between rheumatoid arthritis patients and age-matched healthy volunteers. For both categories, secondary endpoints included differences in: - coronary atherosclerosis as asssed with CCTA - myocardial inflammation, myocardial perfusion and myocardial fibrosis as assesed with CMR In addition, secondary endpoints will also include clinical treatment response in the patients with rheumatoid arthritis, assessed using the American College of Rheumatology response rate, DAS-28 score and biomarkers such as C-reactive protein and erythrocyte sedimentation rate.

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Countries

Netherlands

Outcome results