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NCT06885970: Cytisin-angio

The Effect of Cytisine Treatment for Smoking Cessation on Cardiovascular Function in Adult Smokers

Recruiting now Last updated 2 April 2025
What this trial tests

trial testing Cytisinicline administration in Smoking Cessation in 200 participants. Currently enrolling.

Timeline
12 November 2024
Primary endpoint
22 July 2025
10 August 2025

Quick facts

Lead sponsorUniversity of Athens
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date12 November 2024
Primary completion22 July 2025
Estimated completion10 August 2025
Sites1 location across Greece

Drugs / interventions tested

Conditions studied

Sponsor

University of Athens

Who can join

Adults 18 to 75, any sex, with Smoking Cessation or Arterial Stiffness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Pharmacological interventions can enhance smoking cessation success and long-term abstinence. Cytisine, a plant derived alkaloid, is a selective partial agonist at alpha-4 beta-2 nicotinic acetylcholine receptors, which are crucial in nicotine dependence. Aim of the Study The primary objective of this observational study is to evaluate the efficacy of cytisine in a standard 25-day dosing regimen among adult smokers and users of alternative nicotine products (e-cigarettes or heated tobacco). The study will assess the impact of cytisine on cardiovascular function, including arterial stiffness, cardiac deformation, and endothelial glycocalyx integrity. The secondary aim is to determine relapse rates post-treatment, treatment side effects, and new cardiovascular events during the treatment period and at six-month follow-up. Materials and Methods: This observational study will recruit smokers visiting the smoking cessation unit at the 2nd Department of Cardiology, Attikon University Hospital, Athens. All participants will receive counseling and treatment from the attending physician. A minimum of 200 participants will be enrolled, categorized into: • At least 50 receiving cytisine in the standard dosing regimen: Days 1-3: 1 tablet every 2 hours (6 tablets daily) Days 4-12: 1 tablet every 2.5 hours (5 tablets daily) Days 13-16: 1 tablet every 3 hours (4 tablets daily) Days 17-20: 1 tablet every 5 hours (3 tablets daily) Days 21-25: 1-2 tablets daily * At least 50 receiving nicotine replacement therapy * At least 50 receiving prolonged cytisine therapy (3 mg, three times daily for 12 weeks) * At least 50 who do not intend to quit smoking (control group) Assessments will be conducted at baseline, one month, and six months post-recruitment. The following measurements will be performed: A. Arterial Stiffness: Pulse wave velocity (cf-PWV) using the Complior device to measure arterial stiffness, Augmentation index and pulse wave velocity using the Arteriograph device via brachial artery cuff. B. Endothelial Glycocalyx Integrity: Perfused boundary region (PBR) assessment of sublingual microvasculature using a Sidestream Dark Field (SDF) camera. C. Cardiac Function: Left ventricular ejection fraction (LVEF), myocardial strain (GLS), and myocardial work assessment via speckle-tracking echocardiography (Echopac 203, GE Horten Norway).The investigators will also calculate myocardial work (MW) using pressure-strain loop analysis. D. Oxidative Stress: Plasma malondialdehyde (MDA) and protein carbonyl (PC) levels measured via spectrophotometry. E. Smoking Cessation Monitoring: Exhaled carbon monoxide (CO) measured using a commercial device (Smokelyzer, Bedfont Scientific Ltd.). This study aims to provide valuable insights into cytisine's effectiveness in smoking cessation and its impact on cardiovascular health.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The effects of cytisinicline for smoking cessation on arterial stiffness, endothelial function, and myocardial performance: a pilot study.
    Ikonomidis I, Thymis J, Kostelli G, Katogiannis K, et al · · 2025 · cited 1× · PMID 40469528 · DOI 10.1093/ehjimp/qyaf062

Verify or expand the search:

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

Other University of Athens trials

Trials by the same sponsor.

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Data sources for this page

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