Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT04848506
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2021-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events observed during dosing of aficamten in patients with HCM', 'timeFrame': 'Baseline to End of study, up to 5 years', 'description': 'Patient incidence of reported Adverse Events (AEs)'}], 'secondaryOutcomes': [{'measure': 'Incidence of serious adverse events observed during dosing of aficamten in patients with HCM', 'timeFrame': 'Baseline to End of study, up to 5 years', 'description': 'Patient incidence of reported Serious Adverse Events (SAEs)'}, {'measure': 'Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM', 'timeFrame': 'Baseline to End of study, up to 5 years', 'description': 'Patient incidence of reported LVEF \\<50%'}, {'measure': 'Long-term effects of aficamten on left ventricular outflow tract gradient (LVOT G) in patients with oHCM', 'timeFrame': 'Baseline through the end of participation at 12-24 week intervals', 'description': 'Peak LVOT-G at rest; applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on resting LVOT-G', 'timeFrame': 'Baseline through the end of participation at 12-24 week intervals', 'description': 'Proportion of patients with resting LVOT-G \\< 30 mmHg; applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on post Valsalva LVOT-G', 'timeFrame': 'Baseline through the end of participation at 12-24 week intervals', 'description': 'Proportion of patients with post-Valsalva LVOT-G \\< 50 mmHg; applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on post Valsalva LVOT-G', 'timeFrame': 'Baseline through the end of participation at 12-24 week intervals', 'description': 'Proportion of patients with post-Valsalva LVOT-G \\< 30 mmHg; applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on left ventricular ejection fraction (LVEF) and post-Valsalva LVOT-G', 'timeFrame': 'Baseline through the end of participation at 12-24 week intervals', 'description': 'Proportion of patients with LVEF ≥ 50%, resting LVOT-G \\< 30 mmHg, and post-Valsalva LVOT-G \\< 50 mmHg; applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on time to first resting LVOT-G < 30 mmHg through last follow-up', 'timeFrame': 'Time to the following event through last follow-up, up to 5 years', 'description': 'Applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 50 mmHg through last follow-up', 'timeFrame': 'Time to the following event through last follow-up, up to 5 years', 'description': 'Applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on time to first post-Valsalva LVOT-G < 30 mmHg through last follow-up', 'timeFrame': 'Time to the following event through last follow-up, up to 5 years', 'description': 'Applicable only to patients with oHCM'}, {'measure': 'Long-term effects of aficamten on time to first LVEF ≥ 50%, resting LVOT-G < 30 mmHg, and post-Valsalva LVOT-G < 50 mmHg through last follow-up', 'timeFrame': 'Time to the following event through last follow-up, up to 5 years', 'description': 'Applicable only to patients with oHCM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Hypertrophic Cardiomyopathy', 'oHCM', 'CK-3773274', 'CK-274', 'Non obstructive hypertrophic cardiomyopathy', 'nHCM', 'HCM', 'Hypertrophic cardiomyopathy', 'Aficamten', 'REDWOOD-OLE', 'CY 6022', 'FOREST-HCM', 'Forest'], 'conditions': ['Symptomatic Hypertrophic Cardiomyopathy (HCM)']}, 'referencesModule': {'references': [{'pmid': '40540987', 'type': 'DERIVED', 'citation': 'Saberi S, Abraham TP, Choudhury L, Barriales-Villa R, Elliott PM, Nassif ME, Oreziak A, Owens AT, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Coats CJ, Fifer MA, Sherrid MV, Solomon SD, Watkins H, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Melloni C, Meng L, Wei J, Maron MS, Masri A; FOREST-HCM Steering Committee and Investigators. Aficamten Treatment for Symptomatic Obstructive Hypertrophic Cardiomyopathy: 48-Week Results From FOREST-HCM. JACC Heart Fail. 2025 Aug;13(8):102496. doi: 10.1016/j.jchf.2025.03.040. Epub 2025 Jun 19.'}, {'pmid': '40285763', 'type': 'DERIVED', 'citation': 'Masri A, Maron MS, Abraham TP, Nassif ME, Barriales-Villa R, Bilen O, Coats CJ, Elliott P, Garcia-Pavia P, Massera D, Olivotto I, Oreziak A, Owens AT, Saberi S, Solomon SD, Tower-Rader A, Heitner SB, Jacoby DL, Melloni C, Wei J, Sherrid MV; REDWOOD-HCM, SEQUOIA-HCM, and FOREST-HCM Investigators. Concomitant Aficamten and Disopyramide in Symptomatic Obstructive Hypertrophic Cardiomyopathy. JACC Heart Fail. 2025 Apr 2:102441. doi: 10.1016/j.jchf.2025.03.008. Online ahead of print.'}, {'pmid': '39477631', 'type': 'DERIVED', 'citation': 'Masri A, Choudhury L, Barriales-Villa R, Elliott P, Maron MS, Nassif ME, Oreziak A, Owens AT, Saberi S, Tower-Rader A, Rader F, Garcia-Pavia P, Olivotto I, Nagueh SF, Wang A, Heitner SB, Jacoby DL, Kupfer S, Malik FI, Melloni C, Meng L, Wei J, Sherrid MV, Abraham TP; FOREST-HCM Investigators. Standard-of-Care Medication Withdrawal in Patients With Obstructive Hypertrophic Cardiomyopathy Receiving Aficamten in FOREST-HCM. J Am Coll Cardiol. 2024 Nov 5;84(19):1839-1849. doi: 10.1016/j.jacc.2024.09.002.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect long-term safety and tolerability data for aficamten.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of a Cytokinetics trial investigating aficamten\n* LVEF ≥ 55% at the Screening Visit\n\nExclusion Criteria:\n\n* Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.\n* Has participated in another investigational device or drug study or received an investigational device or drug \\< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.\n* Since completion of a previous trial of aficamten has:\n\n * Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \\< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \\< 100 bpm and/or rhythm is stable \\> 30 days\n * Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)\n* Had a confirmed LVEF \\< 40% with an associated dose interruption during participation in a prior study with aficamten\n* History of implantable ICD placement within 30 days prior to screening.'}, 'identificationModule': {'nctId': 'NCT04848506', 'acronym': 'FOREST-HCM', 'briefTitle': 'Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytokinetics'}, 'officialTitle': 'A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)', 'orgStudyIdInfo': {'id': 'CY 6022'}, 'secondaryIdInfos': [{'id': '2020-003571-17', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-508963-58-00', 'type': 'OTHER', 'domain': 'EU CTR Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aficamten up to 20 mg', 'description': 'Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.', 'interventionNames': ['Drug: Aficamten (5 - 20 mg)']}], 'interventions': [{'name': 'Aficamten (5 - 20 mg)', 'type': 'DRUG', 'description': 'Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.', 'armGroupLabels': ['Aficamten up to 20 mg']}]}, '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': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart and Vascular Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Building - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'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': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedar-Sinai Medical Center', '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': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'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 Hospital / Cardiology Associates', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'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 Fayette Hospital', 'geoPoint': {'lat': 33.44873, 'lon': -84.45493}}, {'zip': '60208', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Hospital & Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine - University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center)', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Westchester Medical Center', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Sanger Heart & Vascular Institute - 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