Recruiting
Phase 4
Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis
About this study
The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.
- Condition
- Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis
- Tested
- Acoramidis (AG10) oral tablet
- Sponsor
- Eidos Therapeutics, a BridgeBio company
Who can join
- Age
- 18 to 80 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Maximum age: 80 years
- Study condition: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM), Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis
- 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.
Exclusion 7
- 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
1 site, 1 recruiting
Washington University in St. Louis
St Louis, Missouri, United States
Contact
-
Medical Information
1-844-550-2246 medinfo@bridgebio.com
Potential match only. Final eligibility is determined by the study team.