Status:
RECRUITING
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Transthyretin (TTR) Amyloid Cardiomyopathy
Eligibility:
All Genders
30-80 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Other known causes of cardiomyopathy
- History of light-chain cardiac amyloidosis
- Cardiac transplantation
- Liver transplantation
- 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
Key Trial Info
Start Date :
December 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07196839
Start Date
December 31 2025
End Date
March 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75248