Aortic Bioprosthesis Structural Valve DysfunctionPhase 4TEP-SVDNCT03015818
Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
A Phase 4 study testing 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT in people with Aortic Bioprosthesis Structural Valve Dysfunction, run by Nantes University Hospital at 1 site in France.
Trial summary
Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Bioprosthesis Structural Valve Dysfunction
- What is being tested?
- 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2017to 3 May 2019
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18
- written informed consent
- SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient > 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.
Who cannot join
- Inability to give informed consent
- Pregnancy
- Concurrent antibiotherapy
- Certain infectious endocarditis
- Concurrent anti-inflammatory therapy, including corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.
This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.
- Being tested
- 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CTOther
18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
| Study group | Role | What they receive |
|---|---|---|
| 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT | Experimental | Not described Receives: Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-Fluoride activity
18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.
Measured: The day of the inclusion
Secondary outcomes (2)
TBR in 18F-FDG
TBR in 18F-FDG will be compared between the two groups to analyze the inflammatory activity part in the SVD process
Measured: 6 months
Both 18F-Fluoride and 18F-FDG TBR correlation
Both 18F-Fluoride and 18F-FDG TBR will be correlated with bioprosthesis calcium scoring and the following echocardiographic bioprosthesis function parameters : aortic regurgitation grade (none, trace, mild, moderate, severe) ; trans-valvular maximal velocity (m/s) ; mean trans-valvular gradient (mm Hg) ; EOA (cm²) ; visual echographic degenerescence score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start30 Jan 2017
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Bioprosthesis Structural Valve DysfunctionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015818
- Sponsor's protocol ID
- RC16_0137
- Acronym
- TEP-SVD
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2017
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Osteoblastic Activity With 18F-Fluoride in Aortic Bioprosthesis Structural Valve Dysfunction (SVD)
- ClinicalTrials.gov ID
- NCT03015818
- Acronym / sponsor ID
- TEP-SVD / RC16_0137
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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.
Structural valve dysfunction (SVD) is the most common and life threatening complication in patients treated by aortic valve replacement. A calcification process is frequently involved in SVD but its pathophysiology remains unclear. In the hypothesis of an active metabolic phenomenon of calcification, as previously shown in native aortic valve stenosis, rather than a passive deposit of calcium in valve tissue, positon emission tomography (PET) imaging with 18F-Fluoride could emphasize increased osteoblastic activity in SVD tissue.
This study will include patients with echocardiography-confirmed SVD. Echocardiographic parameters and other current parameters analyzed in SVD patients such as bioprosthesis calcium scoring derived from CT will be compared to 18F-Fluoride activity.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT | Experimental | Other: 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18
- written informed consent
- SVD defined on echocardiography by an alteration of bioprosthesis leaflets function with a mean transvalvular gradient > 20 mmHg and maximal velocity ≥ 3 m/s and effective orifice area ≤1.2 cm², and/or an aortic regurgitation more or equal to grade 2 on 4.
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Pregnancy
- Concurrent antibiotherapy
- Certain infectious endocarditis
- Concurrent anti-inflammatory therapy, including corticosteroid therapy
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 |
|---|---|---|
| 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT | Other | 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT |
Primary outcome
18F-Fluoride activity
Time frame: The day of the inclusion
18F-Fluoride activity in valvular tissue will be determined by a tissue to bloodpool ratio of SUV (TBR). Patients will be divided in two groups : moderate SVD (EOA ≥ 0.8 and ≤ 1.2 cm²), and severe SVD (EOA ≤ 0.8 cm²), and TBR will be compared between the two groups, determined at time of inclusion.
2 secondary outcomes
TBR in 18F-FDG
Time frame: 6 months
Both 18F-Fluoride and 18F-FDG TBR correlation
Time frame: 6 months
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 18 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT in people with Aortic Bioprosthesis Structural Valve Dysfunction, run by Nantes University Hospital at 1 site in France.
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 5 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 18 Jan 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
18F-Fluoride activity (time frame: The day of the inclusion). 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 18 Jan 2020.