bTAVI: Improved HRV, Inflammation Markers and Endothelial Function After TAVI

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT04286893

Collaborator

(none)

Enrollment

Location

12.7

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Aortic Stenosis TAVI	Diagnostic Test: Flow mediated vasodilatation Diagnostic Test: High resolution ECG Diagnostic Test: Blood withdrawal

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 9, 2019

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Jul 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
TAVI group Consecutive patients undergoing TAVI	Diagnostic Test: Flow mediated vasodilatation Measurement of brachial artery diameter change before and after limb ischaemia. Diagnostic Test: High resolution ECG Measurement HRV using high resolution ECG Diagnostic Test: Blood withdrawal Measurement of endothelial inflammation markers

Arm

Intervention/Treatment

TAVI group

Consecutive patients undergoing TAVI

Diagnostic Test: Flow mediated vasodilatation

Measurement of brachial artery diameter change before and after limb ischaemia.

Diagnostic Test: High resolution ECG

Measurement HRV using high resolution ECG

Diagnostic Test: Blood withdrawal

Measurement of endothelial inflammation markers

Outcome Measures

Primary Outcome Measures

Change of heart rate variability [3 to 6 months after TAVI]
Change of heart rate variability (HRV) estimated with digital high resolution ECG recording
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

TAVI

Exclusion Criteria:

stage V chronic kidney disease
active malignancies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMC Ljubljana	Ljubljana		Slovenia	1000

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators

Study Director: Borut Jug, PhD, University Medical Centre Ljubljana

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luka Vitez, Luka Vitez, MD, cardiology resident, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT04286893

Other Study ID Numbers:

UKCLbTAVI

First Posted:

Feb 27, 2020

Last Update Posted:

Nov 10, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aortic Valve Stenosis

Inflammation

Study Results

No Results Posted as of Nov 10, 2020