Improved HRV, Inflammation Markers and Endothelial Function After TAVI

NCT ID: NCT04286893

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-09

Study Completion Date

2020-07-31

Brief Summary

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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

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Conditions

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Severe Aortic Stenosis TAVI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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TAVI group

Consecutive patients undergoing TAVI

Flow mediated vasodilatation

Intervention Type DIAGNOSTIC_TEST

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

High resolution ECG

Intervention Type DIAGNOSTIC_TEST

Measurement HRV using high resolution ECG

Blood withdrawal

Intervention Type DIAGNOSTIC_TEST

Measurement of endothelial inflammation markers

Interventions

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Flow mediated vasodilatation

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

Intervention Type DIAGNOSTIC_TEST

High resolution ECG

Measurement HRV using high resolution ECG

Intervention Type DIAGNOSTIC_TEST

Blood withdrawal

Measurement of endothelial inflammation markers

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* TAVI

Exclusion Criteria

* stage V chronic kidney disease
* active malignancies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Luka Vitez

Luka Vitez, MD, cardiology resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Borut Jug, PhD

Role: STUDY_DIRECTOR

University Medical Centre Ljubljana

Locations

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UMC Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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. doi: 10.4244/EIJY14M10_02.

Reference Type RESULT
PMID: 25287265 (View on PubMed)

Vitez L, Starc V, Jug B, Bunc M. Improved Endothelial and Autonomic Function after Transcatheter Aortic Valve Implantation. Rev Cardiovasc Med. 2023 May 8;24(5):140. doi: 10.31083/j.rcm2405140. eCollection 2023 May.

Reference Type DERIVED
PMID: 39076751 (View on PubMed)

Other Identifiers

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UKCLbTAVI

Identifier Type: -

Identifier Source: org_study_id