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Clinical Trials/NCT04286893
NCT04286893
Completed
Not Applicable

Improved Heart Rate Variability, Inflammation Markers and Endothelial Function After Transcatheter Aortic Valve Implantation

University Medical Centre Ljubljana1 site in 1 country50 target enrollmentJuly 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Aortic Stenosis
Sponsor
University Medical Centre Ljubljana
Enrollment
50
Locations
1
Primary Endpoint
Change of laboratory value of endothelial inflammation markers
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.

Registry
clinicaltrials.gov
Start Date
July 9, 2019
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luka Vitez

Luka Vitez, MD, cardiology resident

University Medical Centre Ljubljana

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • stage V chronic kidney disease
  • active malignancies

Outcomes

Primary Outcomes

Change of laboratory value of endothelial inflammation markers

Time Frame: 3 to 6 months after TAVI

Laboratory determined numerical changes in endothelial inflammation markers

Change of flow-mediated filatation (FMD) of the brachial artery

Time Frame: 3 to 6 months after TAVI

% flow-mediated dilatation

Change of heart rate variability

Time Frame: 3 to 6 months after TAVI

Change of heart rate variability (HRV) estimated with digital high resolution ECG recording

Study Sites (1)

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