Subclinical Impairment of Cardiovascular System in Patients With Psoriasis

NCT ID: NCT05957120

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2022-11-30

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients on local therapy

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

No interventions assigned to this group

Patients on methotrexate

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

No interventions assigned to this group

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

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

No interventions assigned to this group

Patients on biologic therapy with anti-interleukin-17

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

No interventions assigned to this group

Patients on biologic therapy with anti-interleukin-23

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

No interventions assigned to this group

Controls

20 subjects who are age-matched

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Eva Klara Merzel Šabović

Eva Klara Merzel Šabović, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Klara Merzel Sabovic, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

References

Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study. Immunol Res. 2025 Jan 8;73(1):28. doi: 10.1007/s12026-024-09584-4.

Reference Type: DERIVED

PMID: 39775226 (View on PubMed)

Merzel Sabovic EK, Kraner Sumenjak T, Bozic Mijovski M, Janic M. Arterial function is preserved in successfully treated patients with psoriasis vulgaris. Sci Prog. 2024 Oct-Dec;107(4):368504241287893. doi: 10.1177/00368504241287893.

Reference Type: DERIVED

PMID: 39403781 (View on PubMed)

Merzel Sabovic EK, Kraner Sumenjak T, Janic M. Residual metabolic burden in young psoriasis patients successfully treated with biologics. Arch Dermatol Res. 2024 Sep 27;316(9):647. doi: 10.1007/s00403-024-03403-4.

Reference Type: DERIVED

PMID: 39331218 (View on PubMed)

Other Identifiers

PICANTI

Identifier Type: -

Identifier Source: org_study_id