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Observational Study on TTR Stabilizing Therapy for ATTR-CM

This observational study is looking at how well existing treatments like tafamidis or acoramidis work in people with transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM), a heart condition. Researchers want to see if these medications, which stabilize TTR, can lower the levels of certain protein clumps called circulating TTR amyloid aggregates (TAAs) in your blood over time. Lower TAA levels would suggest the treatment is effectively reducing the disease activity. You might be able to join if you are between 30 and 80 years old and have symptomatic ATTR-CM, which means you've had heart failure symptoms like hospitalization or elevated blood markers. The study aims to enroll 50 participants and is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will monitor participants who are already taking TTR stabilizing therapy. It aims to enroll 50 participants.
What's involved
You would have blood tests to measure circulating TTR amyloid aggregates at the beginning of the study, then again at 1 month and 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months after the initial blood test.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07196839

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

Recruiting
Not specifiedAges 30–80Observational
University of Texas Southwestern Medical Center
~50 participants
Updated 2026-01-07 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Serial blood levels of circulating TTR amyloid aggregates (TAAs)
Measured over Baseline, 1 month (+/- 5 days), and 3 months (+/- 5 days).

Conditions

Transthyretin (TTR) Amyloid Cardiomyopathy

Explore related trials

Transthyretin related familial amyloid cardiomyopathy

NCT07196839

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UT Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Justin Grodin, MD MPH · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Jerah Sanchez
[email protected]
214-645-7303
Email the study team

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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

What this trial measures

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

    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.