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NCT04286893 Clinical Trial

Improved HRV, Inflammation Markers and Endothelial Function After TAVI

Severe Aortic Stenosis Clinical Trial

— bTAVI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04286893
Other study ID # UKCLbTAVI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 9, 2019
Est. completion date July 31, 2020

Study information
Verified date November 2020
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - TAVI Exclusion Criteria: - stage V chronic kidney disease - active malignancies

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Flow mediated vasodilatation
Measurement of brachial artery diameter change before and after limb ischaemia.
• High resolution ECG
Measurement HRV using high resolution ECG
• Blood withdrawal
Measurement of endothelial inflammation markers

Locations
Country Name City State
Slovenia UMC Ljubljana Ljubljana

Sponsors (1)
Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (1)

Horn P, Stern D, Veulemans V, Heiss C, Zeus T, Merx MW, Kelm M, Westenfeld R. Improved endothelial function and decreased levels of endothelium-derived microparticles after transcatheter aortic valve implantation. EuroIntervention. 2015 Apr;10(12):1456-63 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change of heart rate variability Change of heart rate variability (HRV) estimated with digital high resolution ECG recording 3 to 6 months after TAVI
Primary Change of laboratory value of endothelial inflammation markers Laboratory determined numerical changes in endothelial inflammation markers 3 to 6 months after TAVI
Primary Change of flow-mediated filatation (FMD) of the brachial artery % flow-mediated dilatation 3 to 6 months after TAVI
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