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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03135496
Acronym
DYVA2
Enrollment
51
Registered
2017-05-01
Start date
2017-01-05
Completion date
2019-01-04
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Endothelial Dysfunction

Brief 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).

Interventions

OTHERStudy of endothelial function biological markers

Study of endothelial function biological markers

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Analysis of the variation of the following endothelial function markers: angiopoetin 1 and 2 depending on whether or not extracorporeal circulation1 week

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026