Clinical trial NCT05957120: Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
Official title: Subclinical Impairment of Cardiovascular System in Patients With Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Inflammation
Endothelial Dysfunction
Metabolic Disturbance
Insulin Resistance
Coagulation Disorder
Thrombocyte Disorders
Keywords: Psoriasis
Endothelial dysfunction
Inflammation
Insulin resistance
Biologic therapy
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 5 groups of patients with psoriasis that are treated in our hospital with either local treatment, methotrexate, adalimumab, secukinumab or guselkumab will be included in the study. Included patients will be aged 30 to 45 years and will be without other chronic disease besides psoriasis and without other treatment besides antipsoriatic treatment to investigate the isolated effect of psoriasis on observed parameters (endothelial function, endothelial activation, inflammation, insulin resistance, metabolic disturbances, activation of coagulation and activation of platelets).

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.

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

Primary outcomes:
measure: Arterial function - endothelial function
timeFrame: through study completion, an average of 6 months
measure: Arterial function - arterial stiffness
timeFrame: through study completion, an average of 6 months
measure: Endothelial activation
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Inflammation
timeFrame: through study completion, an average of 6 months
measure: Insulin resistance
timeFrame: through study completion, an average of 6 months
measure: Metabolic disturbances - dyslipidemia
timeFrame: through study completion, an average of 6 months
measure: Metabolic disturbances
timeFrame: through study completion, an average of 6 months
measure: Liver steatosis
timeFrame: through study completion, an average of 6 months
measure: Coagulation
timeFrame: through study completion, an average of 6 months
measure: Activation of hemostasis
timeFrame: through study completion, an average of 6 months
measure: Activation of coagulation
timeFrame: through study completion, an average of 6 months
measure: Platelet activation (1)
timeFrame: through study completion, an average of 6 months
measure: Platelet activation (2)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Eva Klara Merzel Sabovic, MD
role: PRINCIPAL_INVESTIGATOR
References: