Clincosm LogoSign in Get a demo

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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04820959
Collaborator
(none)
80
Enrollment
1
Location
24.9
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Biopsies
  • Biological: Blood sampling
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Actual Study Start Date :
Oct 4, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Myocardial fibrosis rate [Through study completion, an average of 1 year]

    Measurement of the level of myocardial fibrosis in myocardial tissue.

  2. Rate of PCPE-1/2 [Through study completion, an average of 1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Dijon Bourgogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04820959
Other Study ID Numbers:
  • BOUCHOT ANR 2017
First Posted:
Mar 29, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Valve Diseases
Fibrosis

Study Results

No Results Posted as of Oct 27, 2021