Severe Aortic StenosisbTAVINCT04286893
Improved HRV, Inflammation Markers and Endothelial Function After TAVI
An observational study of Severe Aortic Stenosis and TAVI, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Aortic Stenosis, TAVI
- What is being tested?
- Flow mediated vasodilatation, High resolution ECG and Blood withdrawal
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 9 Jul 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Consecutive patients eligible for transfemoral transcatheter aortic valve implantation
Who may be able to join
- TAVI
Who cannot join
- stage V chronic kidney disease
- active malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Severe Aortic Stenosis, TAVI
- Being tested
- Flow mediated vasodilatation, High resolution ECG, Blood withdrawal
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow mediated vasodilatationDiagnostic test
Measurement of brachial artery diameter change before and after limb ischaemia.
High resolution ECGDiagnostic test
Measurement HRV using high resolution ECG
Blood withdrawalDiagnostic test
Measurement of endothelial inflammation markers
| Study group | Role | What they receive |
|---|---|---|
| TAVI group | Consecutive patients undergoing TAVI Receives: Diagnostic Test: Flow mediated vasodilatation; Diagnostic Test: High resolution ECG; Diagnostic Test: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of heart rate variability
Change of heart rate variability (HRV) estimated with digital high resolution ECG recording
Measured: 3 to 6 months after TAVI
Change of laboratory value of endothelial inflammation markers
Laboratory determined numerical changes in endothelial inflammation markers
Measured: 3 to 6 months after TAVI
Change of flow-mediated filatation (FMD) of the brachial artery
% flow-mediated dilatation
Measured: 3 to 6 months after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start9 Jul 2019
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luka Vitez, University Medical Centre Ljubljana
- Investigators
- Borut Jug, PhD, Study director, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286893
- Sponsor's protocol ID
- UKCLbTAVI
- Acronym
- bTAVI
- Status last verified
- Nov 2020
- First submitted
- 21 Feb 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25287265Vitez 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.
PubMed 39076751
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Heart Rate Variability, Inflammation Markers and Endothelial Function After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT04286893
- Acronym / sponsor ID
- bTAVI / UKCLbTAVI
- Conditions
- Severe Aortic Stenosis, TAVI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAVI group | – | Diagnostic Test: Flow mediated vasodilatation, Diagnostic Test: High resolution ECG, Diagnostic Test: Blood withdrawalConsecutive patients undergoing TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients eligible for transfemoral transcatheter aortic valve implantation
Key inclusion criteria (1 listed)
- TAVI
Key exclusion criteria (2 listed)
- stage V chronic kidney disease
- active malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow mediated vasodilatationMeasurement of brachial artery diameter change before and after limb ischaemia. | Diagnostic test | TAVI group |
| High resolution ECGMeasurement HRV using high resolution ECG | Diagnostic test | TAVI group |
| Blood withdrawalMeasurement of endothelial inflammation markers | Diagnostic test | TAVI group |
Primary outcome
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
Change of laboratory value of endothelial inflammation markers
Time frame: 3 to 6 months after TAVI
Laboratory determined numerical changes in endothelial inflammation markers
Change of flow-mediated filatation (FMD) of the brachial artery
Time frame: 3 to 6 months after TAVI
% flow-mediated dilatation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Results publication: PubMed 25287265Horn 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.
- Derived from this study: PubMed 39076751Vitez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borut Jug, PhD study director
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Aortic Stenosis and TAVI, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of heart rate variability (time frame: 3 to 6 months after TAVI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04286893, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.