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

NCT04820959 | Completed

• 1 other identifier: BOUCHOT ANR 2017
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvulopathy; Heart Surgery; Procollagen C-Proteinase Enhancers

Outcome Measures

Primary Outcomes (2)

• Myocardial fibrosis rate

  Measurement of the level of myocardial fibrosis in myocardial tissue.

  Through study completion, an average of 1 year

• Rate of PCPE-1/2

  Measurement of PCPE-1/2 rate in myocardial tissue.

  Through study completion, an average of 1 year

Interventions

Biopsies BIOLOGICAL

Three endomyocardial intraoperative biopsies were performed on the left ventricle. Resection of the left atrium in the event of atrial fibrillation.

Blood sampling BIOLOGICAL

Pre-operative blood sampling

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Punctures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: October 4, 2020
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

FR (1)