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

Recruiting

• Conditions: arthritis; joint disorder; 10028593; 10023213

• Registration Number: NL-OMON51028
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 105

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

- 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 <70mm Hg, second or third degree AV nodal
conduction disturbances)
- Contraindications to CMR or CCTA (e.g. claustrophobia, ferromagnetic
implants, known allergy to iodinated or gadolinium based contrast agents,
weight or size exceeding the limits of the CMR or CCTA scanner.
- Contraindications to treatment with JAK inhibitors (e.g. history of deep vein
thrombosis or pulmonary embolism, known malignancy, planned major surgery,
active infection)
- Current smoking
- Estimated Glomerular Filtration Rate <30 mL/min/1.73m2
- Pregnancy
- Participation in a trial with an investigational drug or treatment.
- History of noncompliance with medical therapy
- Unwilling or unable to provide written informed consent or comply with the
study protocol
- Life expectancy less than 1 year.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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