Tracking blood amyloid levels in people with heart amyloidosis taking stabilizing medicine
Follows amyloid in blood over time in people with transthyretin cardiac amyloidosis.
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Dallas, United StatesSee the site
- Trial code
- Registry title
- Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
- Status
- Recruiting
- People taking part
- 50 people, planned
- Started
- 31 Dec 2025
- Expected to end
- Mar 2027
- Type of study
- Observational, 2 groups
- Record updated
- 7 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 30 to 80 with symptomatic ATTR cardiac amyloidosis and a history of heart failure. It studies blood TTR amyloid levels over time.
- Age
- 30 to 80 years
- Sex
- Men and women
- Disease stage
- Symptomatic ATTR cardiac amyloidosis (ATTR-CA) with a history of heart failure: a hospital stay for heart failure in the past 12 months, raised BNP of 100 pg/mL or more or NT-proBNP of 360 pg/mL or more in the past 12 months, or a heart failure diagnosis by a treating clinician.
- Earlier treatment
- Either about to start on-label TTR-stabilizing therapy (for example tafamidis) within 5 days after joining, or already taking it. Cannot have taken patisiran in the past 90 days, inotersen in the past 180 days, or ever taken vutrisiran.
- Biomarker or test result
- ATTR-CA previously diagnosed by tissue staining and typing, or by bone scintigraphy without abnormal M-protein. TTR gene sequencing result must be available or pending.
Main reasons for not taking part
- Other known causes of cardiomyopathy
- History of light-chain cardiac amyloidosis
- Heart or liver transplant
- Taking part in a clinical trial for ATTR treatments
- Estimated glomerular filtration rate of 30 mL/min/1.73 m2 or lower
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Men and women ages 30-80 who have symptomatic ATTR-CA as determined by a history of HF (this will be assessed by study personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- ATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein
- TTR gene sequencing confirming the TTR genotype has resulted or is pending
- Enrollment will be stratified by n/N=30/50 starting on-label TTR-stabilizing therapy (e.g. tafamidis) within 5 days after enrollment or by n/N=20/50 of those currently taking TTR-stabilizing therapy
Who cannot take part
- Liver transplantation
- History of light-chain cardiac amyloidosis
- Cardiac transplantation
- Other known causes of cardiomyopathy
- Has taken patisiran in the past 90 days, or inotersen in the past 180 days, has ever taken vutrisiran, or is participating in a clinical trial for ATTR treatments
- Estimated glomerular filtration rate ≤30 mL/min/1.73 m2
- Anticipated gaps in ATTR-CA treatment for 3 months after enrollment
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Where in United States
- UT Southwestern Medical CenterDallas, United StatesContact: Jerah SanchezTaking people
About the trial
What the trial wants to find out
The objective of this study is to determine the association of clinically prescribed, on-label, TTR stabilizing therapy (e.g. tafamidis or acoramidis) with levels of circulating transthyretin amyloid aggregates (TAAs, a surrogate for amyloid disease activity) measured serially over time in patients with transthyretin cardiac amyloidosis (ATTR-CA). To accomplish this objective, the hypothesis that TTR stabilizing therapy will be associated lower circulating TAAs over time will be tested. Completion of this study will advance the understanding of the influence of ATTR-CA treatments on circulating evidence of amyloidosis and justify the role of blood testing to monitor treatment response in patients with ATTR-CA.
The 2 groups in the trial
- Taking on-label TTR stabilizing treatment
Taking on-label TTR stabilizing treatment for \>14 days prior to enrollment
- Initiating on-label TTR stabilizing treatment
Initiating on-label TTR stabilizing treatment within 5 days after enrollment
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
- Plain-language title
- Tracking blood amyloid levels in people with heart amyloidosis taking stabilizing medicineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07196839, who can take part
- Record updated
- 7 January 2026