Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers

Not Applicable

Completed

• Conditions: Procollagen C-Proteinase Enhancers; Valvulopathy; Heart Surgery

• Registration Number: NCT04820959
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Heart failure is characterized by cardiac fibrosis linked to extracellular collagen deposits. Collagens are synthesized as soluble precursors, procollagens, which must undergo proteolytic maturation to assemble into fibres. This step is under the control of two extracellular proteins, procollagen C-proteinase enhancer 1 and 2 (PCPE-1 and -2). The mechanism of action of these highly effective and specific activators was recently elucidated by one of our partners. Preliminary results, as well as data from the literature, indicate a strong correlation between the expression rates of PCPEs and cardiac fibrosis. The aim of this study is to validate in humans, by analysis of endomyocardial tissue biopsies, the hypothesis that PCPEs contribute to the anarchic accumulation of collagen during cardiac fibrosis and to evaluate the interest of developing new diagnostic and therapeutic strategies for cardiac fibrosis using PCPE agonists.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-04
• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Primary Completion: 2022-07-07
• Study Completion: 2022-07-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Person who has given written consent
• Patient aged 18 to 85 for men and 60 to 85 for women
• Patient requiring cardiac surgery for aortic valve replacement or aortic plastic surgery or aortic plasty or ascending aorta replacement more or less associated with aortic valve surgery

Exclusion Criteria

• Person not affiliated or not benefiting from national health insurance
• Person subject to a measure of legal protection (curatorship, guardianship)
• Person deprived of liberty, by judicial or administrative decision
• Major incapable or incapable of giving consent
• Minor
• Pregnant or breastfeeding woman
• Emergency Surgery
• Acute Infectious Endocarditis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Myocardial fibrosis rate	Through study completion, an average of 1 year	Measurement of the level of myocardial fibrosis in myocardial tissue.
Rate of PCPE-1/2	Through study completion, an average of 1 year	Measurement of PCPE-1/2 rate in myocardial tissue.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France