Inflammatory Response in Aortic Valve Replacement

The Impact of Genetic Variability on Perioperative Morbidity and Mortality. Substudy: Inflammatory Response in Patients Undergoing Aortic Valve Replacement.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02324140

Enrollment

101

Registered

2014-12-24

Start date

2012-06-30

Completion date

2015-05-31

Last updated

2015-07-14

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

Conditions

Aortic Valve Stenosis, Inflammation, Systemic Inflammatory Response Syndrome, Thoracic Surgery

Brief summary

The study investigates inflammatory and antiinflammatory response in patients with severe aortic valve stenosis needing either surgical treatment (surgical aortic valve replacement) or interventional cardiology treatment (transcatheter aortic valve implantation using the transfemoral access route or the transapical access route).

Detailed description

Background Surgical and interventional therapy for aortic valve stenosis exposes the patients to a immune reaction, which is different depending on the type of the treatment. In this study, the investigators would like to better understand the inflammatory and antiinflammatory response in this patient population by monitoring the perioperative cytokine response (interleukins), the human leukocyte antigen expression (HLA-DR) and assessing soluble plasma factors (CD62L) involved in inflammatory processes. Objective Characterisation of inflammatory and antiinflammatory response in patients receiving aortic valve prosthesis selected for different treatment options. Methods Whole blood analysis at different time points (preoperatively, 4 / 24 /48 hours postoperatively) for different inflammatory and antiinflammatory markers: IL-6, IL-8, IL-10, CRP, TNF, soluble CD62L.

Interventions

OTHERWhole blood analysis

In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Written informed consent * Severe aortic valve stenosis * Surgical aortic valve replacement * Transcatheter aortic valve implantation * No previous inflammatory condition

Exclusion criteria

* Missing informed consent * Treatment with corticosteroids * Treatment with antibiotics

Design outcomes

Primary

Measure	Time frame
Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)	Perioperative period ending after 48 hours postoperatively

Secondary

Measure	Time frame
Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)	Perioperative period ending after 48 hours postoperatively
In-hospital mortality	In-hospital treatment until discharge (7-10 days)

Countries

Switzerland

Outcome results

None listed

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