Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

Summary

The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.

Interventions

• Acoramidis (AG10) oral tablet · DRUG

  Study drug is defined as acoramidis 712 mg (equivalent to 800 mg acoramidis hydrochloride) taken orally twice daily for 36 months of open label treatment.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Washington University in St. Louis, St Louis, Missouri · RECRUITING