The Effect of Transaortic Valve Replacement on the Endothelial Integrity and Function

Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects.

The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.

Study Overview

• Status: Completed
• Conditions: Degenerative Aortic Valve Stenosis

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Germany
  • Dusseldorf, Germany, 40225
    • Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Participation Criteria

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

patients with aortic valve stenosis screened for TAVI

Description

Inclusion Criteria:

• aortic valve stenosis
• screened for TAVI
• written informed consent

Exclusion Criteria:

• no written informed consent
• Patients with acute infections (CRP> 0.5 mg / dL)
• Patients with Atrial Fibrillation
• Patients with inflammatory and malignant diseases

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelial function	endothelial function will be measured by flow mediated dilation (FMD)	Changes from Baseline in endothelial function at 3 months
plasma levels of circulating microparticles (MPs)		Changes from Baseline in Plasma Levels of MPs at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arterial stiffness	arterial stiffness will be measured by pulse wave analysis	Changes from Baseline in arterial stiffness at 3 months
blood pressure		Changes from Baseline in Hemodynamics at 3 months
heart rate		Changes from Baseline in Hemodynamics at 3 months

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, Professor, Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 20, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: endothelial function; transaortic valve replacement (TAVI); circulating microparticles
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MP TAVI