Aneurysm Aortic RootNCT04205474
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
A study testing graded bicycle test in people with Aneurysm Aortic Root and Aortic Valve, Bicuspid, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneurysm Aortic Root, Aortic Valve, Bicuspid
- What is being tested?
- graded bicycle test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Dec 2019to 1 Jan 2021
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000
- being able to perform an exercise test on a reclining bicycle
- normal left ventricular function
Who cannot join
- <18 years or >60 years of age
- peak gradient across the aortic valve at rest of >20mmHg
- decreased left ventricular function
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Cardiac Surgery, University Hospital
Ghent, België, 9000
About this study
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.
This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract.
Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.
Read the detailed description
In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and with gradients at rest across the aortic valve of <20mmHg, a graded exercise test on a bicycle (stepwise increase of afterload) will be performed, and the gradient across the aortic valve will be monitored by transthoracic echocardiography at each exercise level. Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and asymptomatic control group with normal functioning tricuspid and bicuspid valves will be examined with the same exercise protocol.
The purpose of the study is the description of the gradients across the aortic valve during exercise, and the discrimination of risk factors that may induce increased gradients.
The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than patients with tricuspid valves, in operated and unoperated individuals.
- Conditions
- Aneurysm Aortic Root, Aortic Valve, Bicuspid
- Being tested
- graded bicycle test
- Keywords
- valve sparing procedure, reimplantation
- Medical subject headings
- Aortic Root Aneurysm, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
graded bicycle testDiagnostic test
the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload
| Study group | Role | What they receive |
|---|---|---|
| VSRR with tricuspid aortic valve | Active comparator | Patients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm Receives: Diagnostic Test: graded bicycle test |
| VSRR with bicuspid aortic valve | Active comparator | Patients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm Receives: Diagnostic Test: graded bicycle test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level
obtained with transthoracic echocardiography during exercise- echocardiographic flow velocity across the aortic valve (colour flow Doppler) and in the left ventricular outflow tract (pulsed-wave Doppler) were measured at regular time intervals during grade exercise, and during recovery - examination was recorded digitally
Measured: from 1 year postoperatively
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves
obtained with transthoracic echocardiography during exercise, at each exercise level
Measured: from 1 year postoperatively
Secondary outcomes (1)
comparison between gradients across aortic valve in unoperated and operated patients
gradients in mmHg across the aortic valve, measured by transthoracic echocardiography, at increasing afterload levels, on a reclining bicycle
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start16 Dec 2019
- Primary completion10 Sep 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm Aortic RootStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Francois, MD, PhD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205474
- Sponsor's protocol ID
- HCH_VSRR_1
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2019
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
- ClinicalTrials.gov ID
- NCT04205474
- Acronym / sponsor ID
- HCH_VSRR_1
- Conditions
- Aneurysm Aortic Root, Aortic Valve, Bicuspid
- Keywords
- valve sparing procedure, reimplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 Dec 2019 (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.
Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.
This results in a normal functioning aortic valve, with a low forward gradient across the left ventricular outflow tract.
Little is known about how the repaired aortic valve behaves in conditions of controlled exercise, and how the gradients across the valve change during exercise.
Detailed description
In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and with gradients at rest across the aortic valve of <20mmHg, a graded exercise test on a bicycle (stepwise increase of afterload) will be performed, and the gradient across the aortic valve will be monitored by transthoracic echocardiography at each exercise level. Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and asymptomatic control group with normal functioning tricuspid and bicuspid valves will be examined with the same exercise protocol.
The purpose of the study is the description of the gradients across the aortic valve during exercise, and the discrimination of risk factors that may induce increased gradients.
The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than patients with tricuspid valves, in operated and unoperated individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSRR with tricuspid aortic valve | Active comparator | Diagnostic Test: graded bicycle testPatients with a tricuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm |
| VSRR with bicuspid aortic valve | Active comparator | Diagnostic Test: graded bicycle testPatients with a bicuspid valve that previously underwent a valve sparing root procedure for aortic root aneurysm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- been operated with a valve sparing root procedure in the University Hospital Ghent, Belgium, since 2000
- being able to perform an exercise test on a reclining bicycle
- normal left ventricular function
Key exclusion criteria (3 listed)
- <18 years or >60 years of age
- peak gradient across the aortic valve at rest of >20mmHg
- decreased left ventricular function
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 |
|---|---|---|
| graded bicycle testthe subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload | Diagnostic test | VSRR with bicuspid aortic valve, VSRR with tricuspid aortic valve |
Primary outcome
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level
Time frame: from 1 year postoperatively
obtained with transthoracic echocardiography during exercise- echocardiographic flow velocity across the aortic valve (colour flow Doppler) and in the left ventricular outflow tract (pulsed-wave Doppler) were measured at regular time intervals during grade exercise, and during recovery - examination was recorded digitally
comparison between peak gradients in mmHg across tricuspid and bicuspid aortic valves
Time frame: from 1 year postoperatively
obtained with transthoracic echocardiography during exercise, at each exercise level
1 secondary outcome
comparison between gradients across aortic valve in unoperated and operated patients
Time frame: 1 year
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 28 Dec 2022.
- 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.
Katrien Francois, MD, PhD principal investigator
University Hospital Ghent, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graded bicycle test in people with Aneurysm Aortic Root and Aortic Valve, Bicuspid, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 3 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 28 Dec 2022. 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 Belgium. 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?
Echocardiographic gradients in mmHg and velocity across the aortic valve in m/sec at each exercise level (time frame: from 1 year postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Dec 2022.