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Aficamten for Hypertrophic Cardiomyopathy (ACACIA-HCM Trial)

Phase 3
Recruiting
Research Sponsored by Cytokinetics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA class II or III
Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex
Must not have
Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM
History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study, week 72
Awards & highlights
Pivotal Trial

Summary

This trial is testing aficamten, a medication that may help people with a thickened heart muscle condition. It aims to improve their quality of life and ability to exercise. The drug works by making the heart muscle less stiff, which could help the heart pump blood better.

Who is the study for?
Adults aged 18-85 with non-obstructive hypertrophic cardiomyopathy (nHCM), specifically those who are somewhat limited in physical activity but not bedridden. They must have a body mass index under 40, no recent heart surgeries or treatments with similar drugs, and be able to exercise on a treadmill or bicycle.
What is being tested?
The trial is testing Aficamten against a placebo to see if it improves life quality, exercise ability, and health outcomes for people with nHCM. Participants will either receive the actual drug or a placebo without knowing which one they're getting.
What are the potential side effects?
While specific side effects of Aficamten aren't listed here, common ones for heart medications may include dizziness, changes in blood pressure or heart rhythm, fatigue, headache, and potential gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart condition mildly or moderately affects my daily activities.
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My exercise test shows I use a lot of oxygen and my peak oxygen level is low for my age and sex.
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I have been diagnosed with non-obstructive hypertrophic cardiomyopathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition that causes thickening of the heart muscle, similar to nHCM.
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My heart's pumping strength is below normal.
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I have low oxygen levels without extra oxygen or severe lung/blood pressure issues.
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I have had fainting spells or dangerous heart rhythms during exercise in the last 3 months.
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My high blood pressure has not improved with treatment.
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I have been treated with aficamten before.
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I have a type of irregular heartbeat known as atrial fibrillation.
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I have a severe blockage in my heart's arteries or had a heart attack before.
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I have been treated with mavacamten within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study, week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study, week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Secondary study objectives
Change in LAVI
Change in NT-proBNP
Change in composite of two Z-scores of CPET parameters (pVO2 and VE/VCO2 slope)
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AficamtenExperimental Treatment1 Intervention
Participants in this arm will receive a single daily oral dose of 5 mg, 10 mg, 15 mg, or 20 mg of aficamten with dose levels guided by echocardiography assessments, for up to 72 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants in this arm will receive placebo, for up to 72 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aficamten
2023
Completed Phase 1
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Hypertrophic Cardiomyopathy (HCM) treatments often target the excessive contractility and abnormal heart muscle thickening characteristic of the disease. Cardiac myosin inhibitors, such as aficamten, work by reducing the hypercontractility of the heart muscle, thereby decreasing the obstruction in the left ventricular outflow tract and improving symptoms. This is crucial for HCM patients as it helps alleviate symptoms like shortness of breath and chest pain, and can improve exercise capacity and overall quality of life. Other common treatments include beta-blockers and calcium channel blockers, which reduce heart rate and contractility, and septal myectomy or alcohol septal ablation, which physically reduce the thickened heart muscle. These treatments collectively aim to manage symptoms, prevent complications, and improve the functional status of HCM patients.

Find a Location

Who is running the clinical trial?

CytokineticsLead Sponsor
41 Previous Clinical Trials
15,232 Total Patients Enrolled
Cytokinetics MDStudy DirectorCytokinetics
3 Previous Clinical Trials
393 Total Patients Enrolled
~242 spots leftby Jun 2026