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

Endothelial Dysfunction Clinical Trial

— DYVA2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135496
• Other study ID #: PI2016_843_0029
• Status: Completed
• Start date: January 5, 2017
• Est. completion date: January 4, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 4, 2019
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Endothelial Dysfunction

Intervention

Other:
• Study of endothelial function biological markers
Study of endothelial function biological markers

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation		1 week