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New treatment option for Transthyretin Amyloid Cardiomyopathy
Official title A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis
ClinicalTrials.gov ID: NCT07298044
What this study is testing
What is Acoramidis?
Acoramidis is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for transthyretin amyloid cardiomyopathy.
Also referred to as BAY3684938, BEYONTTRA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid.
- Phase 4: studies an already-approved treatment
- Time commitment: about 8 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT/Computed Tomography (CT) or...
- Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to...
- New York Heart Association (NYHA) class ≤ II at V1.
- Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 at V1.
You likely can't join if
- Prior liver or heart transplantation or planned within the next 12 months.
- Current or planned use of ventricular assist device.
- Active cancer or other disease that decreases the life expectancy to less than one year.
- Heart failure due to ischemic heart disease.
- Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.
- Confirmed diagnosis of light-chain amyloidosis.
See the full eligibility criteria
- Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.
- Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT/Computed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (V1).
- Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy.
- New York Heart Association (NYHA) class ≤ II at V1.
- Estimate glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 at V1.
- N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) \> 300 and ≤ 7000 pg/mL at V1.
- Prior liver or heart transplantation or planned within the next 12 months.
- Current or planned use of ventricular assist device.
- Active cancer or other disease that decreases the life expectancy to less than one year.
- Heart failure due to ischemic heart disease.
- Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.
- Confirmed diagnosis of light-chain amyloidosis.
- Dialysis or severe renal impairment as reflected by Urinary Albumin Creatinine Ratio (UACR) \> 300 mg/g at V1.
- Major surgery 90 days prior to V1.
- Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.
- Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.
- Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.
- Recent CV hospitalization within 3 months before V1.
- Known hypersensitivity to acoramidis or to any of the excipients.
- A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition.
- Known or suspected liver disorder and bile secretion/flow (cholestasis, also history of it).
- Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1.
The study team makes the final eligibility decision.
Where it's taking place
- Sankt Pölten, Lower Austria, Austria
- Vienna, State of Vienna, Austria
- Vienna, Styria, Austria
- Braunau am Inn, Upper Austria, Austria
- Feldkirch, Vorarlberg, Austria
- Brussels, Brussels Capital, Belgium
- Bruges, West Flanders, Belgium
- Darmstadt, Hesse, Germany
- Bergamo, Italy
- Bologna, Italy
- Florence, Italy
- Lecce, Italy
- Milan, Italy
- Naples, Italy
- Padova, Italy
- Pavia, Italy
- Pisa, Italy
- Siena, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sankt Pölten, Lower Austria, Austria; Vienna, State of Vienna, Austria; Vienna, Styria, Austria; Braunau am Inn, Upper Austria, Austria; Feldkirch, Vorarlberg, Austria; Brussels, Brussels Capital, Belgium and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.