BridgeMD
A study of aficamten (CK-3773274) in adults with symptomatic non-obstructive hypertrophic cardiomyopathy (ACACIA)
EU CTIS ID: 2023-505797-15-00
What this study is testing
To evaluate the effect of aficamten compared with placebo on participant health status and maximal exercise capacity
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Between 18–85 years of age at screening
- Body mass index < 40 kg/m2
- Diagnosed with nHCM and has a screening echocardiogram with the following: • End-diastolic LV wall thickness: − ≥ 15 mm in one or more myocardial segments OR − ≥ 13 mm in one or more wall segments AND a known disease-causing gene mutation or positive family history of HCM AND − Resting LVOT-G < 30 mmHg AND Valsalva LVOT-G < 50 mmHg AND − LVEF ≥ 60% • Participants with a history of intracavitary obstruction are eligible
- New York Heart Association (NYHA) class II or III
- Respiratory exchange ratio of ≥ 1.00 at screening by CPET and predicted peak oxygen uptake (pVO2) of ≤ 90% for age and sex
- KCCQ-CSS score ≤ 85
You likely can't join if
- Significant valvular heart disease (per Investigator judgment) • Moderate or severe valvular aortic stenosis or fixed subaortic obstruction • Moderate or severe mitral regurgitation
- History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
- Screening diastolic blood pressure ≥ 100 mmHg
- Undergone septal reduction therapy < 6 months prior to screening
- Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
- Paroxysmal or permanent atrial fibrillation is excluded only if: • rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to randomization • rate control and anticoagulation have not been achieved for at least 3 months prior to screening
See the full eligibility criteria
- Between 18–85 years of age at screening
- Body mass index < 40 kg/m2
- Diagnosed with nHCM and has a screening echocardiogram with the following: • End-diastolic LV wall thickness: − ≥ 15 mm in one or more myocardial segments OR − ≥ 13 mm in one or more wall segments AND a known disease-causing gene mutation or positive family history of HCM AND − Resting LVOT-G < 30 mmHg AND Valsalva LVOT-G < 50 mmHg AND − LVEF ≥ 60% • Participants with a history of intracavitary obstruction are eligible
- New York Heart Association (NYHA) class II or III
- Respiratory exchange ratio of ≥ 1.00 at screening by CPET and predicted peak oxygen uptake (pVO2) of ≤ 90% for age and sex
- KCCQ-CSS score ≤ 85
- N-terminal prohormone brain natriuretic peptide (NT-proBNP) of: • ≥ 300 pg/mL or ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR • For Black participants, ≥ 225 pg/mL or ≥ 675 pg/mL if in atrial fibrillation or atrial flutter
- Hemoglobin ≥ 10 g/dL
- Significant valvular heart disease (per Investigator judgment) • Moderate or severe valvular aortic stenosis or fixed subaortic obstruction • Moderate or severe mitral regurgitation
- History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)
- Screening diastolic blood pressure ≥ 100 mmHg
- Undergone septal reduction therapy < 6 months prior to screening
- Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period
- Paroxysmal or permanent atrial fibrillation is excluded only if: • rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to randomization • rate control and anticoagulation have not been achieved for at least 3 months prior to screening
- Received prior treatment with aficamten
- Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of Type 1 myocardial infarction.
- History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
- Inability to exercise on a treadmill or bicycle (e.g., orthopedic limitations)
- Documented room air oxygen saturation reading < 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
- History of the following events with exercise within 3 months prior to screening • syncope, • symptomatic ventricular arrhythmia, or • sustained ventricular tachyarrhythmia
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
- Australia
- China
- Israel
- Brazil
- Colombia
- United States
- Argentina
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom; Australia; China; Israel; Brazil and 3 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 EU CTIS; the study team decides eligibility.