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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04820959
Acronym
CARDIACTIV
Enrollment
66
Registered
2021-03-29
Start date
2020-10-04
Completion date
2022-07-07
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery, Procollagen C-Proteinase Enhancers, Valvulopathy

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.

Interventions

BIOLOGICALBiopsies

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

BIOLOGICALBlood sampling

Pre-operative blood sampling

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Myocardial fibrosis rateThrough study completion, an average of 1 yearMeasurement of the level of myocardial fibrosis in myocardial tissue.
Rate of PCPE-1/2Through study completion, an average of 1 yearMeasurement of PCPE-1/2 rate in myocardial tissue.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026