Acoramidis in Transthyretin Cardiac Amyloidosis and Its Effect on Heart Blood Markers
Tests acoramidis in adults with transthyretin cardiac amyloidosis, tracking heart blood markers.
Plain-language title generated from the registry record
Registry title: Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
Key facts
- Where
- Bunkyō City, Kumamoto, Kurume-shi, Kyoto, Mitaka-shi, Nagoya, Nankoku-shi, Okayama, Ōtsu, Sagamihara-shi, Sapporo, Shinjuku-ku, Suita-shi, Tsu, and Yufu-shi, JapanSee the 15 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT07306949, who can take part
Where in Japan
- Bunkyō CityBunkyō City, JapanNot yet recruiting
- KumamotoKumamoto, JapanNot yet recruiting
- Kurume-shiKurume-shi, JapanTaking people
- KyotoKyoto, JapanNot yet recruiting
- Mitaka-shiMitaka-shi, JapanNot yet recruiting
- NagoyaNagoya, JapanNot yet recruiting
- Nankoku-shiNankoku-shi, JapanNot yet recruiting
- OkayamaOkayama, JapanNot yet recruiting
- ŌtsuŌtsu, JapanNot yet recruiting
- Sagamihara-shiSagamihara-shi, JapanNot yet recruiting
- SapporoSapporo, JapanNot yet recruiting
- Shinjuku-kuShinjuku-ku, JapanNot yet recruiting
- Suita-shiSuita-shi, JapanNot yet recruiting
- TsuTsu, JapanNot yet recruiting
- Yufu-shiYufu-shi, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Alexion Pharmaceuticals, Inc.
- Trial code
- NCT07306949
- Record updated
- 7 January 2026
- Original description
The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.Read full original descriptionShow less
A Multicenter, Open-Label, Single Arm, Post-Marketing Clinical Study to Evaluate the Therapeutic Effects of Acoramidis Hydrochlorideon Cardiac Biomarkers and Current Clinical Features in Patients With Transthyretin-type Cardiac Amyloidosis: The CARE ATTR Study
The purpose of this study is to confirm that the treatment with acoramidis prevents the deterioration of the ATTR-CM disease progression index and that these indexes are surrogate markers of disease progression.
Inclusion: Treatment history of ATTR-CM is one of the following:; Naive participants: newly diagnosed with ATTR-CM and no prior treatment with drugs for ATTR-CM; Switch participants: Participants who are using tafamidis, a TTR stabilizer, as treatment for ATTR-CM and who, in the judgment of the post-marketing clinical trial investigator (co-principal investigator), can be expected to benefit from switching to acoramidis; Naive participants must meet the following requirements:; History of hospitalization for heart failure or heart failure symptoms requiring treatment, including diuretics; Echocardiographic end-diastolic ventricular septal thickness greater than 12 millimeters (mm); Confirmed diagnosis of ATTR-CM (wild type or mutant) by one of the following diagnostic methods; Tissue biopsy shows amyloid deposition and TTR precursor protein is identified by immunohistochemistry or mass spectrometry; Bone scintigraphy showing strong accumulation ** (Perugini score ≥ 2) consistent with myocardium and no M protein, negating the possibility of AL amyloidosis.
Exclusion: Likelihood of receiving a heart transplant within 1 year from the time screening begins; Hypersensitivity to acoramidis, its metabolites, or additives in the formulation has been confirmed; In the opinion of the responsible (sub)physician for the post-marketing clinical trial, has a history of drug abuse, alcoholism, or psychiatric disorder that would preclude compliance with this Post-Marketing Clinical Study Protocol; Switch participants: prior treatment with gene silencing agents (pachysilane sodium, butrisilane sodium) as treatment for ATTR-CM (including when specifically scheduled to start treatment with a gene silencing agent); Has a clinically significant medical condition, an abnormal laboratory test result, or a condition that may jeopardize the safety of the study participant, increase the risk of participation in the post-marketing clinical trial, or affect the study; Have confirmed diagnosis of AL amyloidosis; Pregnant or lactating women; Participating in an interventional study other than this study, including a clinical trial.