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

NCT ID: NCT04820959

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-04

Study Completion Date

2022-07-07

Brief Summary

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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

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Conditions

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Valvulopathy Heart Surgery Procollagen C-Proteinase Enhancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Biopsies

Three endomyocardial intraoperative biopsies were performed on the left ventricle.

Resection of the left atrium in the event of atrial fibrillation.

Intervention Type BIOLOGICAL

Blood sampling

Pre-operative blood sampling

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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BOUCHOT ANR 2017

Identifier Type: -

Identifier Source: org_study_id

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