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Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

RecruitingPhase 4

Sponsor: Eidos Therapeutics, a BridgeBio company

Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis

Interventions: Acoramidis (AG10) oral tablet

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

St Louis, Missouri, United States