Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 5:47 AM
Study NCT ID:
NCT06081894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-27', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Kansas City Cardiomyopathy Questionnaire - Clinical Summary Score (KCCQ-CSS)', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on participant health status'}, {'measure': 'Change in pVO2', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on maximal exercise capacity'}], 'secondaryOutcomes': [{'measure': 'Change in composite of two Z-scores of CPET parameters (pVO2 and VE/VCO2 slope)', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on global exercise capacity based on maximal and sub-maximal exercise performance'}, {'measure': 'Proportion of participants with ≥ 1 class improvement in NYHA Functional Class', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on NYHA Functional Classification'}, {'measure': 'Change in NT-proBNP', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on a biomarker of cardiac wall stress'}, {'measure': 'Change in LAVI', 'timeFrame': 'Baseline to Week 36', 'description': 'Effect of aficamten compared with placebo on echocardiographic measures of structural remodeling'}, {'measure': 'Time to first CV event', 'timeFrame': 'Baseline to End of Study, Week 72', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CK-3773274', 'CK-274', 'Aficamten', 'Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy', 'nHCM', 'ACACIA-HCM', 'ACACIA'], 'conditions': ['Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-85 years of age\n* Body mass index \\< 40 kg/m2\n* Diagnosed with nHCM and has a screening echocardiogram with the following:\n\n * End-diastolic left ventricular (LV) wall thickness:\n\n * ≥ 15 mm in one or more myocardial segments OR\n * ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM AND\n * Resting LVOT-G \\< 30 mmHg AND Valsalva LVOT-G \\< 50 mmHg AND\n * LVEF ≥ 60%\n * Participants with a history of intracavitary obstruction are eligible.\n* NYHA class II or III\n* Respiratory exchange ratio of ≥ 1.00 at screening by cardiopulmonary exercise testing (CPET) and predicted peak oxygen uptake (pVO2) ≤ 90% for age and sex\n* KCCQ-CSS score of ≤ 85\n* NT-proBNP of:\n\n * NT-pro BNP ≥ 300 pg/mL or NT-proBNP ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR\n * For Black participants, an NT-pro BNP ≥ 225 pg/mL or NT-proBNP ≥ 675 pg/mL if in atrial fibrillation or atrial flutter\n\nExclusion Criteria:\n\n* Significant valvular heart disease (per Investigator judgment)\n\n * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction\n * Moderate or severe mitral regurgitation\n* Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (eg, Noonan syndrome, Fabry disease, amyloidosis)\n* Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction.\n* History of LV systolic dysfunction (LVEF \\< 45%) or stress cardiomyopathy\n* Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations)\n* Documented room air oxygen saturation reading \\< 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension\n* History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening\n* History of resistant hypertension (persistently elevated blood pressure despite maximal doses of 3 or more classes of medications for hypertension control)\n* Screening diastolic blood pressure ≥ 100 mmHg\n* Received prior treatment with aficamten\n* Received treatment with mavacamten within 3 months prior to screening (must be discussed with the medical monitor prior to screening)\n* Undergone septal reduction therapy \\< 6 months prior to screening\n* Is being considered for or is likely to be considered for heart transplant listing or left ventricular assist device placement during the study period\n* Paroxysmal or permanent atrial fibrillation is excluded only if:\n\n * rhythm restoring treatment (e.g., direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) has been required ≤ 3 months prior to screening\n * rate control and anticoagulation have not been achieved for at least 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT06081894', 'acronym': 'ACACIA-HCM', 'briefTitle': 'Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytokinetics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CY 6033'}, 'secondaryIdInfos': [{'id': '2023-505797-15-00', 'type': 'OTHER', 'domain': 'EU CTR Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aficamten', 'description': '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.', 'interventionNames': ['Drug: Aficamten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive placebo, for up to 72 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aficamten', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Aficamten']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health - Sulpizio Cardiovascular Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medical Center of USC (Outpatient Clinic)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center (Smidt Heart Institute)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center Cardiovascular Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Holy Cross Medical Group - Cardiology Associates', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Drug Services, AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30214', 'city': 'Fayetteville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Heart Institute (CPET)', 'geoPoint': {'lat': 33.44873, 'lon': -84.45493}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "The Queen's Medical Center-Punchbowl", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Ascension St. Vincent', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, 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'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South 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'country': 'Australia', 'facility': 'Flinders Medical Centre Cardiology Research', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6150', 'city': 'Murdoch', 'country': 'Australia', 'facility': 'Fiona Stanley Hospital, AHF Unit', 'geoPoint': {'lat': -32.06987, 'lon': 115.83757}}, {'zip': '40170-0130', 'city': 'Ondina', 'state': 'Salvador', 'country': 'Brazil', 'facility': "Instituto D'Or de Pesquisa e Ensino/Cardio Pulmonar da Bahia SA", 'geoPoint': {'lat': -15.61667, 'lon': -39.7}}, {'zip': '30110-934', 'city': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Fundacao Felice Rocho / Hospital Felicio Rocho', 'geoPoint': {'lat': -8.96667, 'lon': -72.78333}}, {'zip': '30220-140', 'city': 'Minas Gerais', 'country': 'Brazil', 'facility': 'NUPEC Cardio / Cardio HVC', 'geoPoint': {'lat': -8.96667, 'lon': -72.78333}}, {'zip': '14026-900', 'city': 'Ribeirão Preto', 'country': 'Brazil', 'facility': 'CLINICOR Clinica Cardiologica LTDA', 'geoPoint': {'lat': -21.1775, 'lon': 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