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A trial to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow obstruction
EU CTIS ID: 2023-504809-37-00
What this study is testing
To evaluate the effect of aficamten compared with metoprolol on exercise capacity in participants with symptomatic oHCM
- 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
- Males and females between 18 to 85 years of age, inclusive, at the signing of informed consent
- Body mass index < 35 kg/m2, Qualification of BMI for study eligibility is only required at the participant’s first screening visit.
- "Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography: a. Has LV hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and b. Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory: • ≥ 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"
- KCCQ score ≤90 at Screening Visit 2
- "Has a screening echocardiogram with the following as determined by the echocardiography core laboratory: a. Resting LVOT-G > 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND b. LVEF ≥ 60% at screening"
- Hemoglobin ≥ 10g/dL at screening
You likely can't join if
- Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
- History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
- History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
- Current or recent (< 4 weeks prior to signing of informed consent) therapy with disopyramide
- History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
- History of intolerance or medical contraindication to beta blocker therapy
See the full eligibility criteria
Who can join
- Males and females between 18 to 85 years of age, inclusive, at the signing of informed consent
- Body mass index < 35 kg/m2, Qualification of BMI for study eligibility is only required at the participant’s first screening visit.
- "Diagnosed with oHCM per the following criteria by cardiac magnetic resonance imaging (CMR) or echocardiography: a. Has LV hypertrophy with non-dilated LV chamber in the absence of other cardiac disease and b. Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory: • ≥ 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"
- KCCQ score ≤90 at Screening Visit 2
- "Has a screening echocardiogram with the following as determined by the echocardiography core laboratory: a. Resting LVOT-G > 30 mm Hg and/or post-Valsalva LVOT-G ≥ 50 mmHg at screening AND b. LVEF ≥ 60% at screening"
- Hemoglobin ≥ 10g/dL at screening
- Patients previously exposed to mavacamten are allowed to participate but must be off mavacamten for at least 8 weeks
What rules you out
- Medical indication for either beta blocker or calcium-channel blockers prohibiting drug discontinuation other than oHCM
- History of septal reduction therapy (surgical myectomy or alcohol septal ablation) within 6 months of screening
- History of paroxysmal or persistent atrial fibrillation or atrial flutter. Atrial flutter treated with radio frequency ablation without recurrence within the last 6 months prior to screening is allowed.
- Current or recent (< 4 weeks prior to signing of informed consent) therapy with disopyramide
- History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening
- History of intolerance or medical contraindication to beta blocker therapy
- Has received prior treatment with aficamten or previously intolerant (reduced LVEF requiring permanent drug discontinuation) to mavacamten
- Resting SBP of > 160 mmHg at the time of screening
- Resting heart rate of > 100 beats per minute (bpm) at the time of screening
- Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)
- "Significant valvular heart disease a. Moderate-severe valvular aortic stenosis or fixed subaortic obstruction b. Mitral regurgitation not due to systolic anterior motion of the mitral valve (per Investigator judgment)"
- Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
- History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy at any time during their clinical course
- Documented room air oxygen saturation reading < 90% at screening
- Planned septal reduction treatment that cannot be deferred during the trial period
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Argentina
- Canada
- Israel
- China
- United Kingdom
- United States
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 Brazil; Argentina; Canada; Israel; China; United Kingdom and 1 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.