Improved HRV, Inflammation Markers and Endothelial Function After TAVI

Completed

• Conditions: Severe Aortic Stenosis; TAVI

• Registration Number: NCT04286893
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-09
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-08
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• TAVI

Exclusion Criteria

• stage V chronic kidney disease
• active malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia