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Evaluating Aficamten for Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

PHASE3 · Cytokinetics · NCT06081894

This study is testing if a new medication called aficamten can help adults with non-obstructive hypertrophic cardiomyopathy feel better and improve their quality of life compared to a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years to 85 Years
SexAll
SponsorCytokinetics (industry)
Locations135 sites (Birmingham, Alabama and 134 other locations)
Trial IDNCT06081894 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of aficamten compared to a placebo in adults suffering from symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). Participants will be assessed for improvements in quality of life, exercise capacity, and clinical outcomes. The study includes adults aged 18 to 85 with specific echocardiographic and clinical criteria. The trial aims to provide insights into the potential benefits of aficamten for managing nHCM symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 diagnosed with symptomatic non-obstructive hypertrophic cardiomyopathy and meeting specific echocardiographic and clinical criteria.

Not a fit: Patients with obstructive hypertrophic cardiomyopathy or those not meeting the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and clinical outcomes for patients with symptomatic nHCM.

How similar studies have performed: Other studies have shown promise in treating hypertrophic cardiomyopathy with similar approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Between 18-85 years of age
* Body mass index \< 40 kg/m2
* Diagnosed with nHCM and has a screening echocardiogram with the following:

  * End-diastolic left ventricular (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.
* 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
* KCCQ-CSS score of ≤ 85
* NT-proBNP of:

  * NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR
  * For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter

Exclusion Criteria:

* Significant valvular heart disease (per Investigator judgment)

  * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
  * Moderate or severe mitral regurgitation
* Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)
* Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.
* History of LV systolic dysfunction (LVEF \< 45%) or stress cardiomyopathy
* Inability to exercise on a treadmill or bicycle (eg, 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 syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening
* 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
* 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)
* 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 screening
  * rate control and anticoagulation have not been achieved for at least 3 months prior to screening.

Where this trial is running

Birmingham, Alabama and 134 other locations

+85 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy, CK-3773274, CK-274, Aficamten, nHCM, ACACIA-HCM, ACACIA

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.