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

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.

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Key information

Conditions

Valvulopathy Cardiovascular Diseases Heart Diseases Heart Surgery Heart Valve Diseases Procollagen C-Proteinase Enhancers

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Myocardial fibrosis rate

Time frame: Through study completion, an average of 1 year

Measurement of the level of myocardial fibrosis in myocardial tissue.
Rate of PCPE-1/2

Time frame: Through study completion, an average of 1 year

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CARDIACTIV

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Mar 29, 2021
Registry last updated: Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed