NCT04286893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

February 21, 2020

Last Update Submit

November 8, 2020

Conditions

Severe Aortic StenosisTAVI

Outcome Measures

Primary Outcomes (3)

  • Change of heart rate variability

    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

    Laboratory determined numerical changes in endothelial inflammation markers

    3 to 6 months after TAVI

  • Change of flow-mediated filatation (FMD) of the brachial artery

    % flow-mediated dilatation

    3 to 6 months after TAVI

Study Arms (1)

TAVI group

Consecutive patients undergoing TAVI

Diagnostic Test: Flow mediated vasodilatationDiagnostic Test: High resolution ECGDiagnostic Test: Blood withdrawal

Interventions

Flow mediated vasodilatationDIAGNOSTIC_TEST

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

TAVI group
High resolution ECGDIAGNOSTIC_TEST

Measurement HRV using high resolution ECG

TAVI group
Blood withdrawalDIAGNOSTIC_TEST

Measurement of endothelial inflammation markers

TAVI group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive patients eligible for transfemoral transcatheter aortic valve implantation

You may qualify if:

  • TAVI

You may not qualify if:

  • stage V chronic kidney disease
  • active malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (2)

  • 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.

    PMID: 25287265RESULT

  • 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.

    PMID: 39076751DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood withdrawal for endothelial inflammation markers detection

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Borut Jug, PhD

    University Medical Centre Ljubljana

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Luka Vitez, MD, cardiology resident

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 27, 2020

Study Start

July 9, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)