Improved HRV, Inflammation Markers and Endothelial Function After TAVI (bTAVI)

November 8, 2020 updated by: Luka Vitez, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients eligible for transfemoral transcatheter aortic valve implantation

Description

Inclusion Criteria:

  • TAVI

Exclusion Criteria:

  • stage V chronic kidney disease
  • active malignancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 to 6 months after TAVI
Change of laboratory value of endothelial inflammation markers
Time Frame: 3 to 6 months after TAVI
Laboratory determined numerical changes in endothelial inflammation markers
3 to 6 months after TAVI
Change of flow-mediated filatation (FMD) of the brachial artery
Time Frame: 3 to 6 months after TAVI
% flow-mediated dilatation
3 to 6 months after TAVI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKCLbTAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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