Acoramidis for ATTR-CM: Cardiac Imaging Study
Official title: An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Run by Eidos Therapeutics, a BridgeBio company · NCT07695701 · Data updated 2026-11-12
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Eidos Therapeutics, a BridgeBio company Industry-sponsored |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | August 2030 |
| Study ends | November 2030 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07695701 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with confirmed ATTR-CM requiring targeted therapy, NYHA I/II, adequate kidney function (eGFR ≥40), LVEF >35%, LV wall thickness ≥12 mm, and stable heart failure for at least 6 weeks.
✕Probably not a fit
Patients with more advanced heart failure (NYHA III/IV or NAC Stage 3), recent acute cardiac events, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, Phase 4 study will enroll up to about 150 adults with ATTR-CM to receive acoramidis (712 mg twice daily) for up to 36 months, with MRI and echocardiography used to track changes in heart structure and amyloid buildup. Participants will have regular in-clinic and phone visits over about 38 months, including screening and a follow-up period after the last dose. The goal is to see if long-term acoramidis can improve cardiac function and reduce amyloid burden.
Why it matters
Potential benefit: If successful, participants may experience improvements in heart function and structure, potentially slowing disease progression.
How similar studies have gone: Previous imaging-based studies in similar amyloid cardiomyopathy approaches have shown mixed results; this study builds on imaging-driven assessment to clarify potential benefits.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Participants aged 18 to 80 * Confirmed diagnosis of ATTR-CM requiring targeted therapy * At screening: New York Heart Association (NYHA) Class I/II; estimated glomerular filtration rate (eGFR) ≥40 mL/min/1.73m2; left ventricular ejection fraction (LVEF) \>35%; left ventricular (LV) wall thickness ≥12 mm. * Heart failure condition has been clinically stable for at least 6 weeks prior to screening. Key Exclusion Criteria: * Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator). * Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening. * Hemodynamic instability. * Likely to undergo heart transplantation within 12 months from screening. * Confirmed diagnosis of AL amyloidosis at screening. * At screening: NYHA Class III/IV; National Amyloidosis Center (NAC) Stage 3. * Prior or current treatment with acoramidis.
Where it's running
-
Washington University in St. Louis
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Medical Information
- Email: medinfo@bridgebio.com
- Phone: 1-844-550-2246
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Preventing transthyretin amyloidosis in young carriers of a genetic variant
This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.
-
Evaluating Iodine-124 Evuzumitide in Patients with Systemic Amyloidosis
This study is testing how a new imaging agent called iodine-124 evuzumitide works in people with systemic amyloidosis, especially those with heart issues, to see how it affects their organs and overall health.
-
Evaluating the prevalence of transthyretin amyloidosis in heart failure patients
This study is trying to find out how common transthyretin amyloidosis is in older heart failure patients to help catch it early for better treatment.
-
Hungarian National Systemic Amyloidosis Registry
This registry collects medical data from adults with systemic amyloidosis across Hungary to help understand how the disease is diagnosed and treated in real-world practice.
-
Long-term safety of eplontersen in adults with transthyretin amyloidosis, including those with prior liver transplant or severe liver impairment
This study will see if eplontersen remains safe over time for adults with transthyretin amyloidosis, including people who have had a liver transplant or have severe liver problems.
-
Annular ligament biopsy during endoscopic carpal tunnel surgery to screen for transthyretin amyloidosis
This study tests whether a biopsy of the annular ligament during carpal tunnel surgery can reliably indicate transthyretin amyloidosis and match the results of the standard synovial biopsy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.