NCT07196839 Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
| NCT ID | NCT07196839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Transthyretin (TTR) Amyloid Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-12-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-12-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Justin Grodin, MD MPH
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT07196839 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Transthyretin (TTR) Amyloid Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07196839 currently recruiting?
Yes, NCT07196839 is actively recruiting participants. Contact the research team at jerahmarie.sanchez@utsouthwestern.edu for enrollment information.
Where is the NCT07196839 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07196839 clinical trial?
NCT07196839 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Justin Grodin, MD MPH at University of Texas Southwestern Medical Center. The trial plans to enroll 50 participants.