Back to resultsValidation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers (CARDIACTIV)
Primary Purpose
Valvulopathy, Heart Surgery, Procollagen C-Proteinase Enhancers
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biopsies
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Valvulopathy
Eligibility Criteria
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
Sites / Locations
- CHU Dijon BourgogneRecruiting
Outcomes
Primary Outcome Measures
Myocardial fibrosis rate
Measurement of the level of myocardial fibrosis in myocardial tissue.
Rate of PCPE-1/2
Measurement of PCPE-1/2 rate in myocardial tissue.
Secondary Outcome Measures
Full Information
NCT ID
NCT04820959
First Posted
March 25, 2021
Last Updated
October 26, 2021
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT04820959
Brief Title
Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Acronym
CARDIACTIV
Official Title
Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 4, 2020 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvulopathy, Heart Surgery, Procollagen C-Proteinase Enhancers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Biopsies
Intervention Description
Three endomyocardial intraoperative biopsies were performed on the left ventricle.
Resection of the left atrium in the event of atrial fibrillation.
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Pre-operative blood sampling
Primary Outcome Measure Information:
Title
Myocardial fibrosis rate
Description
Measurement of the level of myocardial fibrosis in myocardial tissue.
Time Frame
Through study completion, an average of 1 year
Title
Rate of PCPE-1/2
Description
Measurement of PCPE-1/2 rate in myocardial tissue.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier BOUCHOT
Phone
03.80.29.33.52
Ext
+33
Email
Olivier.bouchot@chu-dijon.fr
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier BOUCHOT
Phone
03.80.29.33.52
Ext
+33
Email
Olivier.bouchot@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Validation of New Therapeutic Targets to Prevent Collagen Accumulation During Cardiac Fibrosis: Procollagen C-proteinase Enhancers
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