Targeted Testing for ATTR Among Aortic Stenosis Patients-... | NCT04363294

Studies
Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot

NCT04363294

Sponsor

University of Texas Southwestern Medical Center

Status

Withdrawn

Last Update Posted

Mar 23, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Aortic Valve Stenosis
Cardiac Amyloidosis

Interventions

PYP scan

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

grant was not approved, no subjects enrolled

Expanded Access Info

Start Date

Mar 2022Estimated

Primary Completion Date

Sep 2022Estimated

Completion Date

Aug 2023Estimated

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 23, 2020

First Posted Date

Apr 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2021

Last Update Posted Date

Mar 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Bavry, Professor of Medicine, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Name	Class
Mid America Heart Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants	Other	Patients who had TAVR and underwent evaluation for ATTR with PYP scan	Diagnostic Test: PYP scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PYP scan	Diagnostic Test	99mTc-labeled pyrophosphate	Participants	Bone scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence ATTR with AVi <0.5	Prevalence of ATTR among participants with AVi <0.5 mm Hg/beats per minute	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	Within 28 days after TAVR when bone scan completed

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity AVi	Sensitivity of AVi <0.5 mm Hg/beats per minute	Within 28 days after TAVR when bone scan completed
Specificity AVi	Specificity of AVi ≥0.5 mm Hg/beats per minute

Other Outcomes

Measure	Description	Time Frame
Prevalence ATTR with s'<6 plus AVi <0.5	Prevalence of ATTR among participants with both s'<6 and AVi <0.5 mm Hg/beats per minute	Within 28 days after TAVR when bone scan completed
Prevalence ATTR with s'≥6 plus AVi <0.5

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age <75 years
Moderate to severe paravalvular aortic regurgitation on post-operative echocardiography

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony A Bavry, MD MPH	University of Texas Southwestern Medical Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The primary investigator will upload de-identified individual data after study results have been published

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Data will become available after study results have been published

Access Criteria

The primary investigator will upload study protocol, statistical analysis plan, informed consent form, and clinical study report after study results have been published

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis
D028227	Amyloid Neuropathies, Familial

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.