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NCT04820959 Clinical Trial

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

Heart Surgery Clinical Trial

— CARDIACTIV  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04820959
Other study ID # BOUCHOT ANR 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2020
Est. completion date July 7, 2022

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date July 7, 2022
Est. primary completion date July 7, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Biopsies
Three endomyocardial intraoperative biopsies were performed on the left ventricle. Resection of the left atrium in the event of atrial fibrillation.
• Blood sampling
Pre-operative blood sampling

Locations
Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Myocardial fibrosis rate Measurement of the level of myocardial fibrosis in myocardial tissue. Through study completion, an average of 1 year
Primary Rate of PCPE-1/2 Measurement of PCPE-1/2 rate in myocardial tissue. Through study completion, an average of 1 year
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