Aortic Valve StenosisNCT04363294
Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot
A study testing PYP scan in people with Aortic Valve Stenosis and Cardiac Amyloidosis, run by University of Texas Southwestern Medical Center.
Trial summary
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who undergo transcatheter aortic valve replacement (TAVR). Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Cardiac Amyloidosis
- What is being tested?
- PYP scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Aug 2023
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Successful implantation of a transcatheter heart valve with a commercially available valve (i.e. Sapien 3, Sapien Ultra, Evolut R, Evolut Pro, Evolut Pro+, or Lotus Edge) for native or bioprosthetic aortic stenosis
- Pre-implantation echocardiography with tissue Doppler imaging, if feasible
- Post-implantation invasive cardiac hemodynamics
Who cannot join
- Age <75 years
- Moderate to severe paravalvular aortic regurgitation on post-operative echocardiography
About this study
Official title: Targeted Testing for Transthyretin Cardiac Amyloid Among Aortic Stenosis Patients-Pilot
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who undergo transcatheter aortic valve replacement (TAVR). The hypothesis of this pilot study is to evaluate if invasive cardiac hemodynamics obtained after TAVR, by using the AortoVentricular index (AVi), can be used as a novel test to help identify participants with ATTR.
Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR.
Read more
Aim 2. To determine if s' from echocardiography plus AVi can enhance the prediction of ATTR among aortic stenosis patients undergoing TAVR.
Aim 3. To design a pilot trial to improve patient outcomes after TAVR by targeted testing for ATTR.
Read the detailed description
Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR. Patients undergoing TAVR for symptomatic severe aortic stenosis, with pre-TAVR echocardiography and post-implantation invasive hemodynamic assessment are eligible for study participation. The AVi will be recorded from post-implantation invasive hemodynamic assessment. Participants will undergo bone scintigraphy (99mTc-pyrophosphate Planar/SPECT imaging) within 28 days after TAVR. Participants with abnormal bone scintigraphy require evaluation for a monoclonal protein with blood/urine laboratory testing, and possible tissue biopsy/Hematology consultation to exclude light-chain amyloidosis. Participants who are ATTR positive will receive comprehensive heart failure management and possible genetic testing to evaluate for mutated ATTR. The prevalence of ATTR will be reported among participants with AVi <0.5 versus ≥0.5 mm Hg/beats per minute. Test performance of AVi to predict ATTR will be reported.
Aim 2. To determine if s' obtained from echocardiography tissue Doppler imaging plus AVi can enhance the prediction of ATTR among aortic stenosis patients undergoing TAVR. The s' will be recorded from pre-TAVR tissue Doppler imaging of the mitral annulus. The prevalence of ATTR will be reported among participants with both s' ≤6 cm/second and AVi <0.5 mm Hg/beats per minute versus s' >6 cm/second and AVi <0.5 mm Hg/beats per minute.
Aim 3. To design a pilot trial to improve patient outcomes after TAVR by targeted testing for ATTR. The change in Kansas City Cardiomyopathy Questionnaire-12 from baseline to 12-months and survival with reasonable quality of life at 12-months will be reported among participants who are ATTR positive vs. ATTR negative.
- Conditions
- Aortic Valve Stenosis, Cardiac Amyloidosis
- Being tested
- PYP scan
- Keywords
- aortic stenosis, transthyretin cardiac amyloid, transcatheter aortic valve replacement, AortoVentricular index, ATTR, TAVR, AVi, invasive cardiac hemodynamics
- Medical subject headings
- Aortic Valve Stenosis, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYP scanDiagnostic test
Also called Bone scan
99mTc-labeled pyrophosphate
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | Patients who had TAVR and underwent evaluation for ATTR with PYP scan Receives: Diagnostic Test: PYP scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence ATTR with AVi <0.5
Prevalence of ATTR among participants with AVi <0.5 mm Hg/beats per minute
Measured: Within 28 days after TAVR when bone scan completed
Prevalence ATTR with AVi ≥0.5
Prevalence of ATTR among participants with AVi ≥0.5 mm Hg/beats per minute
Measured: Within 28 days after TAVR when bone scan completed
Secondary outcomes (4)
Sensitivity AVi
Sensitivity of AVi <0.5 mm Hg/beats per minute
Measured: Within 28 days after TAVR when bone scan completed
Specificity AVi
Specificity of AVi ≥0.5 mm Hg/beats per minute
Measured: Within 28 days after TAVR when bone scan completed
Positive predictive value AVi
Positive predictive value of AVi <0.5 at predicting ATTR
Measured: Within 28 days after TAVR when bone scan completed
Negative predictive value AVi
Negative predictive value of AVi ≥0.5 at ruling out ATTR
Measured: Within 28 days after TAVR when bone scan completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study startMar 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: grant was not approved, no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergoing TAVR for symptomatic severe aortic stenosis, with pre-TAVR echocardiography and post-implantation invasive hemodynamic assessment are eligible for study participation. The AVi will be recorded from post-implantation invasive hemodynamic assessment. Participants will undergo bone scintigraphy (99mTc-pyrophosphate Planar/SPECT imaging) within 28 days after TAVR. Participants with abnormal bone scintigraphy require evaluation for a monoclonal protein with blood/urine laboratory testing, and possible tissue biopsy/Hematology consultation to exclude light-chain amyloidosis. Participants who are ATTR positive will receive comprehensive heart failure management and possible genetic testing to evaluate for mutated ATTR.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mid America Heart Institute
- Responsible party
- Principal investigator, Anthony Bavry, University of Texas Southwestern Medical Center
- Investigators
- Anthony A Bavry, MD MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363294
- Sponsor's protocol ID
- STU-2020-0386
- Status last verified
- Mar 2021
- First submitted
- 23 Apr 2020
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary investigator will upload de-identified individual data after study results have been published
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Testing for Transthyretin Cardiac Amyloid Among Aortic Stenosis Patients-Pilot
- ClinicalTrials.gov ID
- NCT04363294
- Acronym / sponsor ID
- STU-2020-0386
- Conditions
- Aortic Valve Stenosis, Cardiac Amyloidosis
- Keywords
- aortic stenosis, transthyretin cardiac amyloid, transcatheter aortic valve replacement, AortoVentricular index, ATTR, TAVR, AVi, invasive cardiac hemodynamics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: grant was not approved, no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Mid America Heart Institute
- Study start
- Mar 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 27 Apr 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.
Our ultimate goal is to design a multi-center randomized trial to test the hypothesis that targeted testing for transthyretin cardiac amyloid (ATTR) will improve survival and health status among aortic stenosis patients who undergo transcatheter aortic valve replacement (TAVR). The hypothesis of this pilot study is to evaluate if invasive cardiac hemodynamics obtained after TAVR, by using the AortoVentricular index (AVi), can be used as a novel test to help identify participants with ATTR.
Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR.
Aim 2. To determine if s' from echocardiography plus AVi can enhance the prediction of ATTR among aortic stenosis patients undergoing TAVR.
Aim 3. To design a pilot trial to improve patient outcomes after TAVR by targeted testing for ATTR.
Detailed description
Aim 1. To determine if an abnormal AVi value can identify ATTR among aortic stenosis patients undergoing TAVR. Patients undergoing TAVR for symptomatic severe aortic stenosis, with pre-TAVR echocardiography and post-implantation invasive hemodynamic assessment are eligible for study participation. The AVi will be recorded from post-implantation invasive hemodynamic assessment. Participants will undergo bone scintigraphy (99mTc-pyrophosphate Planar/SPECT imaging) within 28 days after TAVR. Participants with abnormal bone scintigraphy require evaluation for a monoclonal protein with blood/urine laboratory testing, and possible tissue biopsy/Hematology consultation to exclude light-chain amyloidosis. Participants who are ATTR positive will receive comprehensive heart failure management and possible genetic testing to evaluate for mutated ATTR. The prevalence of ATTR will be reported among participants with AVi <0.5 versus ≥0.5 mm Hg/beats per minute. Test performance of AVi to predict ATTR will be reported.
Aim 2. To determine if s' obtained from echocardiography tissue Doppler imaging plus AVi can enhance the prediction of ATTR among aortic stenosis patients undergoing TAVR. The s' will be recorded from pre-TAVR tissue Doppler imaging of the mitral annulus. The prevalence of ATTR will be reported among participants with both s' ≤6 cm/second and AVi <0.5 mm Hg/beats per minute versus s' >6 cm/second and AVi <0.5 mm Hg/beats per minute.
Aim 3. To design a pilot trial to improve patient outcomes after TAVR by targeted testing for ATTR. The change in Kansas City Cardiomyopathy Questionnaire-12 from baseline to 12-months and survival with reasonable quality of life at 12-months will be reported among participants who are ATTR positive vs. ATTR negative.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergoing TAVR for symptomatic severe aortic stenosis, with pre-TAVR echocardiography and post-implantation invasive hemodynamic assessment are eligible for study participation. The AVi will be recorded from post-implantation invasive hemodynamic assessment. Participants will undergo bone scintigraphy (99mTc-pyrophosphate Planar/SPECT imaging) within 28 days after TAVR. Participants with abnormal bone scintigraphy require evaluation for a monoclonal protein with blood/urine laboratory testing, and possible tissue biopsy/Hematology consultation to exclude light-chain amyloidosis. Participants who are ATTR positive will receive comprehensive heart failure management and possible genetic testing to evaluate for mutated ATTR.
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Diagnostic Test: PYP scanPatients who had TAVR and underwent evaluation for ATTR with PYP scan |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Successful implantation of a transcatheter heart valve with a commercially available valve (i.e. Sapien 3, Sapien Ultra, Evolut R, Evolut Pro, Evolut Pro+, or Lotus Edge) for native or bioprosthetic aortic stenosis
- Pre-implantation echocardiography with tissue Doppler imaging, if feasible
- Post-implantation invasive cardiac hemodynamics
Key exclusion criteria (2 listed)
- Age <75 years
- Moderate to severe paravalvular aortic regurgitation on post-operative echocardiography
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 |
|---|---|---|
| PYP scanAlso: Bone scan99mTc-labeled pyrophosphate | Diagnostic test | Participants |
Primary outcome
Prevalence ATTR with AVi <0.5
Time frame: Within 28 days after TAVR when bone scan completed
Prevalence of ATTR among participants with AVi <0.5 mm Hg/beats per minute
Prevalence ATTR with AVi ≥0.5
Time frame: Within 28 days after TAVR when bone scan completed
Prevalence of ATTR among participants with AVi ≥0.5 mm Hg/beats per minute
4 secondary outcomes
Sensitivity AVi
Time frame: Within 28 days after TAVR when bone scan completed
Specificity AVi
Time frame: Within 28 days after TAVR when bone scan completed
Positive predictive value AVi
Time frame: Within 28 days after TAVR when bone scan completed
Negative predictive value AVi
Time frame: Within 28 days after TAVR when bone scan completed
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: Yes. The primary investigator will upload de-identified individual data after study results have been published
Related trials for Aortic Valve Stenosis
RecruitingObservational study
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Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
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.
Anthony A Bavry, MD MPH principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing PYP scan in people with Aortic Valve Stenosis and Cardiac Amyloidosis, run by University of Texas Southwestern Medical Center.
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 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: withdrawn, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevalence ATTR with AVi <0.5 (time frame: Within 28 days after TAVR when bone scan completed). 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 23 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.