Southeastern ATTR Amyloidosis Consortium: SEATTRAC Family Registry

NCT05974644 | Not Yet Recruiting

• 1 other identifier: HM20027103
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study design is a prospective registry including asymptomatic and symptomatic patients who carry a pathogenic TTR mutation. The study will enroll patients who meet the inclusion criteria and none of the exclusion criteria until 1000 patients are enrolled, at which point in time the study investigators will evaluate whether further patient accrual is meaningful.

Conditions

Amyloidosis, Hereditary

Outcome Measures

Primary Outcomes (2)

• The predictors and incidence of amyloidosis

  For those enrolled as asymptomatic carriers, it will be assessed if they develop cardiac or extra cardiac amyloidosis

  15 years

• Mortality and/or need for heart transplant

  For those with cardiac hereditary transthyretin amyloidosis (hATTR), it will be assessed how many participants die due to disease or require a heart transplant

  10 years

Study Arms (2)

Asymptomatic carriers

Other: Registry

Patients with cardiac hereditary transthyretin amyloidosis (hATTR)

Other: Registry

Interventions

Registry OTHER

The purpose of this registry is to collect and store health information from people who are carriers of the gene known to cause hereditary amyloidosis and those with a confirmed diagnosis of the disease.

Asymptomatic carriers; Patients with cardiac hereditary transthyretin amyloidosis (hATTR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any carriers of a pathogenic TTR mutation known to cause hATTR amyloidosis will be recruited to the registry.

You may qualify if:

• Over the age of 18 years
• Carrier of a pathogenic hATTR mutation confirmed on whole blood gene testing or mass spectrometry
• Willing to return for required follow-up visits

You may not qualify if:

• Patient having undergone heart transplantation or implantation of mechanical circulatory support
• Patients unable to provide informed consent
• Patients having undergone liver transplantation
• Patients have evidence of light chain amyloidosis

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Amyloidosis, Familial

Interventions

Registries

Condition Hierarchy (Ancestors)

Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Records; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Keyur Shah, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyur Shah, MD

CONTACT

804-828-4571; keyur.shah@vcuhealth.org

Sarah Paciulli, NP

CONTACT

804-828-4571; sarah.paciulli@vcuhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 3, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Duration of the registry

Locations

US (1)