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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Heart Surgery
Valvulopathy
Procollagen C-Proteinase Enhancers

Treatments

Biological: Biopsies
Biological: Blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT04820959
BOUCHOT ANR 2017

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Olivier BOUCHOT

Data sourced from clinicaltrials.gov

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