Evaluation of Endothelial Dysfunction During Aortic Valvular Replacement by Bioprosthesis With and Without Extracorporeal Circulation (DYVA2)

July 17, 2020 updated by: Centre Hospitalier Universitaire, Amiens

Patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). It is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach.

To date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (CEC) or percutaneous (Transcatheter Aortic Valve ImplantationTAVI) without CEC.

Two recent studies have demonstrated a sustained improvement in endothelial function with TAVI. On the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (CEC) could be the result of the interaction between pre-existing endothelial dysfunction And the "operative" aggression associated with the CEC.

Thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to CEC. This phenomenon would not exist in TAVI, and would explain the absence of so-called vascular dysfunction complications (Systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens Picardie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

(Angiopoietin 1 and 2) in two types of populations: one with CEC and one without CEC (TAVI).

Description

Inclusion Criteria:

  • Patient ≥ 18 years.
  • Patient operated on aortic valvular replacement by bioprosthesis in surgery + CEC or TAVI
  • Signed consent.
  • Affiliation to Social Security

Exclusion Criteria:

  • Any other cardiac surgery
  • Mechanical aortic valve replacement
  • Permanent Ac / Fa.
  • Pregnant woman.
  • Curative anticoagulation (AVK, NANCO, heparin).
  • Patient under tutelage or curatelle.
  • Refusal of the patient.
  • Participation in another study.
  • Preoperative sepsis
  • Minor or adult, under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgery with CEC
Other: Study of endothelial function biological markers
Study of endothelial function biological markers
Without CEC
Other: Study of endothelial function biological markers
Study of endothelial function biological markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2017

Primary Completion (Actual)

January 4, 2019

Study Completion (Actual)

January 4, 2019

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 1, 2017

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2016_843_0029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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