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OpenTrials
Completed

NCT Number: NCT02324140

Inflammatory Response in Aortic Valve Replacement

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).

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Key information

Conditions

Inflammation Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome Thoracic Surgery Ventricular Outflow Obstruction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. Anesthesiology and Pain Therapy

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole blood analysis

Other

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.

Primary outcomes

  1. Inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-6, CRP, TNF alpha, CD62L)

    Time frame: Perioperative period ending after 48 hours postoperatively

Secondary outcomes

  1. Anti-inflammatory response, as determined by whole blood analysis of inflammatory biomarkers (IL-8, IL-10)

    Time frame: Perioperative period ending after 48 hours postoperatively

  2. In-hospital mortality

    Time frame: In-hospital treatment until discharge (7-10 days)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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