Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study

Conditions

• Transthyretin (TTR) Amyloid Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

30 Years - 80 Years

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Dec 31, 2025

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Taking on-label TTR stabilizing treatment
  Taking on-label TTR stabilizing treatment for \>14 days prior to enrollment
• Arm: Initiating on-label TTR stabilizing treatment
  Initiating on-label TTR stabilizing treatment within 5 days after enrollment

Primary Outcome Measure

Serial blood levels of circulating TTR amyloid aggregates (TAAs) [ Time Frame: Baseline, 1 month (+/- 5 days), and 3 months (+/- 5 days). ]

Central Contacts

• Jerah Sanchez
  214-645-7303
  [email protected]
• Amy Browning
  [email protected]

Locations (1)

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