Southeastern ATTR Amyloidosis Consortium: SEATTRAC Family Registry

ConditionAmyloidosis, Hereditary

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Registry
Other intervention
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.

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Asymptomatic carriers1 intervention

Group B: Patients with cardiac hereditary transthyretin amyloidosis (hATTR)1 intervention

Trial outcomes

Primary outcomes

The predictors and incidence of amyloidosis

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

Time frame

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

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Virginia Commonwealth University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: