Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 4

Conditions: Smoking Cessation

Treatments: Drug: Varenicline; Drug: nicotine

Study type: Interventional

Funder types: Other

Identifiers

NCT02307045

SMOKING-VAR-NIC-ATTIKON

Details and patient eligibility

About

The integrity of endothelial glucocalyx plays a vital role in vascular permeability and inflammation. Smoking cessation is related with improved vascular function and is a key component of secondary cardiovascular prevention. Pharmacotherapy is a standard component of evidence based smoking cessation treatment. This study was designed to determine the effects medically-aided smoking cessation on glucocalyx thickness and arterial elasticity smoking cessation programs

Full description

The investigators will examine smokers without cardiovascular disease treated with transdermal nicotine patches and/or varenicline at before, 4, 12, 24 and 48 weeks after treatment during validated smoking cessation program. The investigators will measure changes between baseline and 4,12,24, and 48 weeks after treatment of :

1. exhaled carbon monoxide (CO, ppm) and self-reported number of cigarretes/day
2. carotid-femoral pulse wave velocity (PWVc m/sec-Complior SP ALAM) and augmentation index (AI %-Arteriograph,TensioMed)
3. perfused boundary region (PBR) of the sublingual arterial microvessels (ranged from 5-25 micrometers) 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 glucocalyx thickness because of a for deeper penetration of the RBC in the glucocalyx
4. oxidative stress, thrombosis and inflammatory biomarkers in blood samples.

Non smokers of similar age and sex will serve as controls.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Smokers

Exclusion criteria

• Coronary artery disease
• Heart failure
• Diabetes mellitus
• Dyslipidemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups

varenicline

Active Comparator group

Description:

Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po

Treatment:

Drug: Varenicline

nicotine

Active Comparator group

Description:

Nicotine replacement therapy with transdermal patches and/or chewing gums

Treatment:

Drug: nicotine