Actively Recruiting
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
Led by University of Texas Southwestern Medical Center · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 30 to 80 with symptomatic transthyretin cardiac amyloidosis (ATTR-CA) as shown by heart failure history
- Heart failure defined by hospitalization in past 12 months, elevated B-type natriuretic peptide (≥100 pg/mL) or NT-proBNP (≥360 pg/mL) levels, or clinical diagnosis by a doctor
- ATTR-CA diagnosis confirmed by amyloid staining and tissue typing or bone scintigraphy without abnormal M-protein
- TTR gene sequencing results available or pending
- Enrollment includes patients starting on-label TTR stabilizing therapy within 5 days after enrollment or those currently taking TTR stabilizing therapy
You will not qualify if you...
- Other known causes of cardiomyopathy
- History of light-chain cardiac amyloidosis
- Prior cardiac transplantation
- Prior liver transplantation
- Use of patisiran within past 90 days or inotersen within past 180 days, previous use of vutrisiran, or participation in other ATTR treatment trials
- Estimated glomerular filtration rate less than 30 mL/min/1.73 m²
- Expected interruptions in ATTR-CA treatment lasting 3 months after enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75248
Actively Recruiting
Research Team
J
Jerah Sanchez
CONTACT
A
Amy Browning
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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