Effects of Treatment With Biological Agents on Vascular and Cardiac Function in Psoriasis

NCT02144857 | Unknown Phase 4

• 1 other identifier: 213/19-6-12
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis has been associated with an increasing risk for atherosclerosis. The investigators investigated whether surrogate markers of subclinical atherosclerosis, vascular dysfunction and myocardial dysfunction are impaired in patients with psoriasis compared to normal controls ,coronary artery disease patients and untreated hypertension subjects. The investigators also examined the effect of treatment with biological vs no biological agents on vascular and LV function in psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis

  Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on endothelial function as assessed by flow mediated dilatation of the brachial artery, coronary flow reserve and endothelial glycocalyx thickness

  12 weeks

• Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis

  Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23, anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on vascular function as assessed by pulse wave velocity, augmentation index and central aortic blood pressure,

  12 weeks

• Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis

  Comparison of effect (improvement or deterioration) of treatment with biological agents (anti-tumor necrosis factor-a, anti-interleukin 12/23 ,anti-interleukin 17A, or apremilast regimen) with the effects of cyclosporine on cardiac function as assessed by longitudinal myocardial deformation, twisting and untwisting of the left ventricle

  12 weeks

Secondary Outcomes (4)

• Differences and similarities in endothelial function between psoriasis and control groups

  0 and 12 weeks

• Differences and similarities in vascular function between psoriasis and control groups

  0 and 12 weeks

• Differences and similarities in cardiac function between psoriasis and control groups

  0 and 12 weeks

• Effects of anti-inflammatory treatment on prognosis for major adverse cardiovascular events

  4-year follow-up

Study Arms (5)

Anti-TNFa regimen

ACTIVE COMPARATOR

Etanercept 50 mg

Drug: etanercept

Anti IL12/23 regimen

ACTIVE COMPARATOR

ustekinumab 45 mg

Drug: ustekinumab

Cyclosporine regimen

ACTIVE COMPARATOR

Cyclosporine 2.5-3 mg/kg

Drug: cyclosporine

anti-interleukin 17 A regimen

ACTIVE COMPARATOR

secukinumab 300 mg

Drug: Secukinumab

inhibitor of phosphodiesterase-4

ACTIVE COMPARATOR

apremilast 30mg

Drug: Apremilast

Interventions

etanercept DRUG

50 mg

Also known as: Enbrel

Anti-TNFa regimen

ustekinumab DRUG

45 mg

Also known as: Stelara

Anti IL12/23 regimen

cyclosporine DRUG

Cyclosporine 2.5-3 mg/kgr

Also known as: Neoral

Cyclosporine regimen

Secukinumab DRUG

300 mg

Also known as: Cosentyx

anti-interleukin 17 A regimen

Apremilast DRUG

30mg

Also known as: Otezla

inhibitor of phosphodiesterase-4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with psoriasis
• Age and sex matched patients with CAD, with untreated hypertension and healthy subjects

You may not qualify if:

• for psoriasis patients were presence of wall motion abnormalities and ejection fraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonary disease or asthma, moderate or severe valvular heart disease, primary cardiomyopathies and malignant tumors. CAD was excluded in psoriasis patients by absence of clinical history, angina and reversible myocardial ischemia, as assessed by dobutamine stress echocardiography or thallium scintigraphy
• in normal controls, CAD was excluded by the presence of normal ECG, absence of clinical history and absence of reversible ischemia by means of treadmill test or dobutamine stress echocardiography

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Attikon Hospital

Athens, 12462, Greece

RECRUITING

Related Publications (2)

• Ikonomidis I, Pavlidis G, Lambadiari V, Rafouli-Stergiou P, Makavos G, Thymis J, Kostelli G, Varoudi M, Katogiannis K, Theodoropoulos K, Katsimbri P, Parissis J, Papadavid E. Endothelial glycocalyx and microvascular perfusion are associated with carotid intima-media thickness and impaired myocardial deformation in psoriatic disease. J Hum Hypertens. 2022 Dec;36(12):1113-1120. doi: 10.1038/s41371-021-00640-2. Epub 2021 Nov 25.

  PMID: 34819613 DERIVED

• Ikonomidis I, Papadavid E, Makavos G, Andreadou I, Varoudi M, Gravanis K, Theodoropoulos K, Pavlidis G, Triantafyllidi H, Moutsatsou P, Panagiotou C, Parissis J, Iliodromitis E, Lekakis J, Rigopoulos D. Lowering Interleukin-12 Activity Improves Myocardial and Vascular Function Compared With Tumor Necrosis Factor-a Antagonism or Cyclosporine in Psoriasis. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006283. doi: 10.1161/CIRCIMAGING.117.006283.

  PMID: 28899951 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept; Ustekinumab; Cyclosporine; secukinumab; apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Ignatios Ikonomidis, Dr

  University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ignatios Ikonomidis, Dr

CONTACT

2105831264; ignoik@gmail.com

Maria Varoudi, Dr

CONTACT

6909001116; mvaroudi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Cardiology

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 22, 2014
• Study Start: May 30, 2014
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Locations

GR (1)