A Phase 3 interventional study of Aficamten and Placebo in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy, sponsored by Cytokinetics. Active, not recruiting at 180 sites in 20 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Cytokinetics · Phase 3, Interventional, and Treatment
This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.
363 studies on the registry are indexed under Cardiomyopathy, Hypertrophic; 116 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 180 interventional studies indexed under Cardiomyopathy, Hypertrophic.
Browse Cardiomyopathy, Hypertrophic studies →Cytokinetics is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 7 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosed with nHCM and has a screening echocardiogram with the following:
End-diastolic left ventricular (LV) wall thickness:
NT-proBNP of:
Exclusion Criteria:
Significant valvular heart disease (per Investigator judgment)
Paroxysmal or permanent atrial fibrillation is excluded only if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Aficamten
Participants in this arm will receive placebo, for up to 72 weeks.
Drug: Placebo
Oral Tablet
Oral Tablet
Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)
Effect of aficamten compared with placebo on participant health status
Time frame: Baseline to Week 36
Change in pVO2
Effect of aficamten compared with placebo on maximal exercise capacity
Time frame: Baseline to Week 36
Change in composite of two Z-scores of CPET parameters (pVO2 and VE/VCO2 slope)
Effect of aficamten compared with placebo on global exercise capacity based on maximal and sub-maximal exercise performance
Time frame: Baseline to Week 36
Proportion of participants with ≥ 1 class improvement in New York Heart Association (NYHA) Functional Class
Effect of aficamten compared with placebo on NYHA Functional Classification
Time frame: Baseline to Week 36
Change in N-terminal prohormone brain natriuretic peptide (NT-proBNP)
Effect of aficamten compared with placebo on a biomarker of cardiac wall stress
Time frame: Baseline to Week 36
Change in Left Atrial Volume Index (LAVI) in participants without atrial fibrillation or flutter at baseline on ECG
Effect of aficamten compared with placebo on echocardiographic measures of structural remodeling
Time frame: Baseline to Week 36
Time to first cardiovascular (CV) event
Effect of aficamten compared with placebo on cardiovascular events (ie, CV death, heart transplantation or left ventricular assist device, aborted sudden cardiac death, non-fatal stroke, heart failure hospitalization, or cardiac arrhythmia (atrial fibrillation or ventricular tachyarrhythmia) requiring treatment or hospitalization)
Time frame: Baseline to End of Study, Week 72
Showing the first 100 of 180 sites across 20 countries. Choose a country and city above to see the rest.
Plan to share: No
Ran from Aug 2023 to primary completion in Aug 2026, 36 months.
Of 15 phase 3 interventional studies under Cardiomyopathy, Hypertrophic, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 36. This study's 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aficamten
Cardiomyopathy, Hypertrophic →