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Prevalence of Wildtype Amyloid After TAVR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825406
Recruitment Status : Withdrawn (Dr. Bavry is recruiting the same patients for a NIH trial.)
First Posted : January 31, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
North Florida Foundation for Research and Education

Study Description
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Brief Summary:
Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.

Condition or disease
Amyloidosis

Detailed Description:
This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Wildtype Amyloid Among TAVR Patients With Impaired Hemodynamics
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who die or have poor quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 1 to 2 years post TAVR ]
    Measurement tool is the Kansas City Cardiomyopathy Questionnaire (KCCQ)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This research is interested in determining how prevalent wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR) patients with impaired hemodynamics. Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but this condition is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.
Criteria

Inclusion Criteria

  • Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center.
  • Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro).
  • Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment.
  • Willingness to have blood drawn
  • Willingness to complete SF12 quality of life KCCQ

Exclusion Criteria:

--Patient that do not qualify for a TAVR procedure as normal clinical care

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825406


Sponsors and Collaborators
North Florida Foundation for Research and Education
Investigators
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Principal Investigator: Anthony Bavry, MD ACC AHA
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Type Study Protocol To request an electronic copy send email to Anthony.bavry@va.gov or debra.robertson1@va.gov
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
De-identified data set for primary and secondary outcomes measures To request an electronic copy send email to Anthony.bavry@va.gov or Debra.robertson1@va.gov

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Responsible Party: North Florida Foundation for Research and Education
ClinicalTrials.gov Identifier: NCT03825406    
Other Study ID Numbers: #: 201802928
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases