Targeted Testing for ATTR Among Aortic Stenosis Patients-Pilot

NCT04363294 | Withdrawn

• 1 other identifier: STU-2020-0386
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis; Cardiac Amyloidosis

Keywords

aortic stenosis; transthyretin cardiac amyloid; transcatheter aortic valve replacement; AortoVentricular index; ATTR; TAVR; AVi; invasive cardiac hemodynamics

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• Sensitivity AVi

  Within 28 days after TAVR when bone scan completed

• Specificity AVi

  Within 28 days after TAVR when bone scan completed

• Positive predictive value AVi

  Within 28 days after TAVR when bone scan completed

• Negative predictive value AVi

  Within 28 days after TAVR when bone scan completed

Other Outcomes (4)

• Prevalence ATTR with s'<6 plus AVi <0.5

  Within 28 days after TAVR when bone scan completed

• Prevalence ATTR with s'≥6 plus AVi <0.5

  Within 28 days after TAVR when bone scan completed

• KCCQ-12

  1 year after TAVR

Study Arms (1)

Participants

OTHER

Patients who had TAVR and underwent evaluation for ATTR with PYP scan

Diagnostic Test: PYP scan

Interventions

PYP scan DIAGNOSTIC_TEST

99mTc-labeled pyrophosphate

Also known as: Bone scan

Participants

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Mid America Heart Institute: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Anthony A Bavry, MD MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: August 1, 2023
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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