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RecruitingPhase 4

Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 45 days, 30 days
  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study duration for an individual participant is approximately 38 months, including up to 45 days for screening, 36 months for open-label treatment and 1 month follow-up after the last dose of study drug."
  • "Phone visits will occur at Month 3 and every 6 months thereafter up to Month 33."
  • "Participants will be followed throughout their participation in this study and for 30 days (+7 days) after the last dose of study drug."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether acoramidis improves how the heart works and its structure. It is for adults with ATTR-CM, a disease in which a protein called transthyretin builds up in the heart.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 80.
  • Confirmed ATTR-CM that needs treatment aimed at this disease.
  • No or mild limits on physical activity from heart failure (NYHA Class I or II).
  • Kidney filtering rate (eGFR) of at least 40.
  • The heart’s main pumping chamber pumps out more than 35% of its blood with each beat (LVEF).
  • The wall of the heart’s main pumping chamber is at least 12 mm thick.
  • Heart failure has been stable for at least 6 weeks before screening.

Who can't join

  • Have or plan to get an implanted heart device, such as a pacemaker or defibrillator.
  • Had a heart attack, sudden loss of blood flow to the heart, a procedure to restore heart blood flow, a stroke, or a mini-stroke within 90 days before screening.
  • Unstable blood flow or blood pressure.
  • Likely to have a heart transplant within 12 months after screening.
  • Confirmed AL amyloidosis, a different type of protein buildup disease, at screening.
  • Heart failure that greatly limits activity or causes symptoms at rest (NYHA Class III or IV), or advanced disease rated NAC Stage 3, at screening.
  • Past or current treatment with acoramidis.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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