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

Last updated: May 14, 2023
Sponsor: University of Athens
Overall Status: Active - Recruiting

Phase

4

Condition

Warts

Rosacea

Scalp Disorders

Treatment

Secukinumab

ustekinumab

Apremilast

Clinical Study ID

NCT02144857
213/19-6-12
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • for psoriasis patients were presence of wall motion abnormalities and ejectionfraction ≤ 50%, psoriatic arthritis, history of acute coronary syndrome, familialhyperlipidemia, insulin dependent-diabetes mellitus, chronic obstructive pulmonarydisease or asthma, moderate or severe valvular heart disease, primary cardiomyopathiesand malignant tumors. CAD was excluded in psoriasis patients by absence of clinicalhistory, angina and reversible myocardial ischemia, as assessed by dobutamine stressechocardiography or thallium scintigraphy
  • regarding the group of CAD patients, we only included patients without history of STelevation myocardial infarction in order to exclude the presence of transmural scarcompromising myocardial function indices. Thus, CAD patients with wall motionabnormalities and ejection fraction of ≤ 50% were excluded. In addition, exclusioncriteria, were history of acute coronary syndrome without ST-segment elevation withinthe last year, familial hyperlipidemia, insulin dependent-diabetes mellitus, chronicobstructive pulmonary disease or asthma, moderate or severe valvular heart disease,primary cardiomyopathies and malignant tumor
  • in normal controls, CAD was excluded by the presence of normal ECG, absence ofclinical history and absence of reversible ischemia by means of treadmill test ordobutamine stress echocardiography

Study Design

Total Participants: 200
Treatment Group(s): 5
Primary Treatment: Secukinumab
Phase: 4
Study Start date:
May 30, 2014
Estimated Completion Date:
December 31, 2023

Study Description

The investigators will compare patients with psoriasis with age and sex matched normal controls as well as patients with angiographically documented CAD and patients with untreated hypertension (HYP) used as positive control groups

Patients with psoriasis (PS) will be randomized to receive an anti-tumor necrosis-a (TNF-a) ,an anti- interleukin 12/23 regimen, an interleukin 17A antagonist, apremilast (inhibitor of phosphodiesterase-4) or a cyclosporine regimen.

The anti-TNF-agent, Etanercept will be given at a dose 50mg twice weekly for 12 weeks and after then once weekly.

The anti-IL12/23 regimen, Ustekinumab will be given at a dose 45 mg at the first visit, at 4 weeks and every 12 weeks if body weight is up to 90 kgr. For body weight >90kgr dose will be adjusted accordingly.

The IL-17A antagonist regimen namely secukinumab 300 mg SC at weeks 0, 1, 2, 3, and 4 and 300 mg SC once monthly afterwards Apremilast will be given at a dose of 30mg orally twice daily Cyclosporine will be administered at a dose 2.5-3mg/kgr daily.

At baseline , after 12 weeks and one year of treatment, the investigators will measure:

  1. pulse wave velocity (PWVc) augmentation index (AI) central systolic blood pressure (cSBP) (Complior, Alam Medical and Arteriograph,TensioMed)

  2. flow-mediated dilation of the brachial artery (FMD)

  3. carotid intima-media thickness (IMT) by ultrasonography

  4. coronary flow reserve of the LAD (CFR) by Doppler echocardiography

  5. E'/A of mitral annular velocities ,LV longitudinal (GLS -%),strain, and strain rate (LongSr-l/s), peak twisting (Tw -deg),peak twisting (Tw-deg/sec)velocity,untwisting at mitral valve opening (unTw) and untwisting (unTw) velocity using speckle tracking echocardiography .

  6. Perfused boundary region (PBR)of the sublingual arterial microvessels (ranged from 5-25 microns) using Sideview Darkfield imaging. (Microscan, Glycocheck) .The PBR in microvessels is the cell-poor layer which results from the phase separation between the flowing red blood cells (RBC) and plasma.The PBR includes the most luminal part of glycocalyx that does allow cell penetration. Increased PBR is considered an accurate index of reduced endothelial glycocalyx thickness because of a deeper RBC penetration in the glycocalyx.

  7. Fetuin serum levels, markers of oxidative stress such as malondialdehyde (MDA) serum levels, protein carbonyls aw well as thrombosis and inflammation biomarkers

Connect with a study center

  • Attikon Hospital

    Athens, 12462
    Greece

    Active - Recruiting

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