Subclinical Impairment of Cardiovascular System in Patients With Psoriasis (PaS)

University Medical Centre Ljubljana

Status: Completed

Conditions: Psoriasis; Inflammation; Endothelial Dysfunction; Coagulation Disorder; Thrombocyte Disorders; Insulin Resistance; Metabolic Disturbance

Study type: Observational

Funder types: Other

Identifiers

NCT05957120

PICANTI

Details and patient eligibility

About

A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, treated with five different types of antipsoriatic treatment, and 20 healthy patients. All 100 subjects will be subjected to anthropometric measurements, blood will be collected for laboratory tests, and an imaging test will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

Full description

Research design: A cross-sectional study will be conducted, which will include 80 young patients with psoriasis, aged 30-45 years, without other chronic diseases, treated with five different types of treatment (local therapy, methotrexate, inhibitor of tumor necrosis factor α, inhibitor of interleukin 17 and inhibitor of interleukin 23), and 20 healthy patients aged 30-45 years. All 100 subjects will be subjected to anthropometric measurements (measurement of weight, height, systolic and diastolic blood pressure, heart rate, waist circumference), blood will be collected for laboratory tests (full blood count with differential, CRP, serum electrolytes, lipid panel, fasting glucose, HbA1c, alanine aminotransferase, aspartate aminotransferase, creatinine, urea, TNF-alpha, IL-6, IL-12, IL-17, IL-23, hsCRP, IFN-gamma, TRANCE, TRAIL, GDF-15, D-dimer, fibrinogen, overall haemostasis potential, overall coagulation potential, VCAM-1, ECAMs), and an imaging test (flow-mediated dilation and measurement of pulse wave velocity) will be performed to determine the function of the endothelium and arterial stiffness. The results will then be statistically analyzed.

Aim of the study: The impact of chronic systemic inflammation in psoriasis on subclinical defects in the cardiovascular system (endothelial dysfunction, arterial stiffness, insulin resistance, platelet activation, and coagulation activation) and their effects on each other will be studied. In addition, the effect of the five main types of psoriasis treatment on all listed subclinical defects of the cardiovascular system will be investigated. Moreover, it will be investigated whether the type of treatment affects systemic inflammation in psoriasis in the same manner.

Expected results: It is expected that all five groups of patients will differ from each other in terms of the degree of subclinical impairment of the cardiovascular system, depending on the expression of psoriasis and the type of treatment they receive. This will form the basis for establishing preventive measures against cardiovascular diseases in patients with psoriasis.

Enrollment: 100 patients

Sex: All

Ages: 30 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with psoriasis aged 30 to 45 years in stable phase of the disease for at least last 6 months

Exclusion criteria

• any treatment besides treatment of psoriasis
• carotid disease
• heart failure
• atrial fibrillation
• diabetes type 1 or 2
• cardiovascular event in the past
• chronic kidney disease stage 3, 4, 5 or end-stage kidney disease
• psoriatic arthritis or any other rheumatic disease
• malignancy
• menopause in women
• other chronic inflammatory diseases

Trial design

100 participants in 6 patient groups

Patients on local therapy

Description:

20 patients on local antipsoriatic therapy (either corticosteroid cream/ointment, calcipotriol or combination (corticosteroid and calcipotriol); duration of treatment varies in cohort of patients

Patients on methotrexate

Description:

20 patients on methotrexate with dosage adjusted by weight; duration of treatment varies in cohort of patients

Patients on biologic therapy with anti-tumor necrosis factor-alpha

Description:

20 patients on adalimumab - 40 mg every two weeks (or 40 mg weekly if the response was previously insufficient); duration of treatment varies in cohort of patients

Patients on biologic therapy with anti-interleukin-17

Description:

20 patients on secukinumab - 300 mg monthly (or 300 mg every two weeks if the response was previously insufficient); duration of treatment varies in cohort of patients

Patients on biologic therapy with anti-interleukin-23

Description:

20 patients on guselkumab - 100 mg every 8 weeks; duration of treatment varies in cohort of patients

Controls

Description:

20 subjects who are age-matched