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NCT07196839 · ClinicalTrials.gov registry record
Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study
A clinical trial of Transthyretin (TTR) Amyloid Cardiomyopathy, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT07196839: Recruiting study of Transthyretin (TTR) Amyloid Cardiomyopathy, sponsored by University of Texas Southwestern Medical Center.
NCT07196839 is a study of Transthyretin (TTR) Amyloid Cardiomyopathy that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07196839, a study of Transthyretin (TTR) Amyloid Cardiomyopathy, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The primary hypothesis is that TTR stabilizing therapy will lower circulating evidence of amyloidosis in patients with ATTR-CA from baseline to 3 months. In addition, the study team expects that there will be a time\*treatment interaction identifying that treatment initiation will have a differential effect on serial levels of circulating s over time than those currently on treatment. These observations will support the role for measuring circulating TAAs to monitor treatment response in ATTR-CA
Conditions Studied
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-12-31 |
| Est. Completion | 2027-03 |
What NCT07196839 shows while recruiting
NCT07196839 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.
The record links to 1 condition, with Transthyretin (TTR) Amyloid Cardiomyopathy appearing as the primary indexed condition, and to 0 interventions.
NCT07196839 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07196839 about?
NCT07196839 is a clinical study titled "Determining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study". 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 ...
What is the current status of trial NCT07196839?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-12-31. Estimated completion is 2027-03.
What conditions does trial NCT07196839 study?
This clinical trial studies the following conditions: Transthyretin (TTR) Amyloid Cardiomyopathy.
Who is sponsoring clinical trial NCT07196839?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07196839 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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