Autophagy and Venous Endothelial Function

NCT04138134 | Unknown

• 1 other identifier: 9-2019
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The molecular mechanisms involved in venous endothelial dysfunction are largely unknowns. Autophagy is an intracellular mechanism devoted to the removal of damaged cytoplasmic elements. Previous evidence demonstrated that activation of autophagy exerts beneficial effects in the cardiovascular system, reducing cardiac damage and improving cardiac function in response to stress. However, the association between venous endothelial dysfunction and autophagy remains to be characterized. In this study the investigators will test whether reactivation of autophagy through a natural compound (spermidine) is able to improve vascular function in saphenous veins derived from patients subjected to saphenectomy. The same outcome will be evaluated in saphenous veins isolated from patients with atherosclerotic obstructive disease of the lower limbs subjected revascularization through implantation of venous by-pass.

Conditions

Venous Disease

Keywords

autophagy; spermidine

Outcome Measures

Primary Outcomes (1)

• Evaluation of endothelial function in venous samples from patients with venous insufficiency before and after treatment with autophagy enhancer spermidine

  Ex vivo vascular reactivity experiments performed on isolated veins treated or not with spermidine ex vivo.

  Immediately after the sampling

Secondary Outcomes (2)

• Impact of autophagy on endothelial venous function

  6 months

• Correlation between autophagy, oxidative stress and endothelial function

  6 months

Study Arms (2)

Group 1

Patients subjected to saphenectomy due to chronic venous insufficiency or varicose veins

Group 2

Patients with atherosclerotic obstructive disease of lower limbs

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* Subjects affected by chronic venous insufficiency or varicose veins undergoing surgical procedure of saphenectomy. * Patients with atherosclerotic obstructive disease of the lower limbs subjected revascularization through implantation of venous by-pass.

You may qualify if:

• Eligible subjects undergoing saphenectomy
• Patients with chronic venous insufficiency
• Patients with varicose veins
• Eligible subjects undergoing peripheral artery revascularization through implantation of venous by-pass derived from saphenous vein
• Acceptance and signature of the informed consent

You may not qualify if:

• Chronic and acute Inflammatory diseases
• Immunological and rheumatic diseases
• Pre-existing or ongoing neoplasms
• Infectious diseases
• Previous organ transplantation
• Treatment with pharmacological therapies able to modulate autophagy, i. e. rapamycin and derivative compounds (rapalogues).
• Antioxidant therapies in the last three months
• Patients with surgical technical complications

Sponsors & Collaborators

• Neuromed IRCCS: lead
• Principal investigator: Giacomo Frati: collaborator
• Co-investigator: Francesco Pompeo: collaborator

Study Sites (1)

IRCCS Neuromed

Pozzilli, Isernia, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous sample

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: February 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: April 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IT (1)