Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-01 @ 11:17 AM
Study NCT ID:
NCT06412666
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-05-09', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Valsalva left ventricular outflow tract gradient (LVOT-G)', 'timeFrame': 'Baseline to week 12'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in resting LVOT-G', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Change in values of NT-proBNP', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Change in values of hs-cTnI', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Change in New York Heart Association (NYHA) Functional Class', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Proportion of patients with ≥1 class improvement in NYHA Functional Class', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Trough observed plasma concentration (Ctrough) and C2h postdose of aficamten', 'timeFrame': 'Baseline to week 12'}, {'measure': 'Maximum observed concentration (Cmax), tmax, AUCtau, and Ctrough of aficamten', 'timeFrame': 'Week 8 or Week 12', 'description': 'A voluntary intensive PK substudy may occur at Week 8 or Week 12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CK-3773274', 'CK-274', 'Aficamten', 'Symptomatic Obstructive Hypertrophic Cardiomyopathy', 'oHCM', 'CEDAR', 'CEDAR-HCM', 'CY 6023'], 'conditions': ['Pediatric', 'Symptomatic Obstructive Hypertrophic Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '41347307', 'type': 'DERIVED', 'citation': 'Kaski JP, Kantor PF, Nakano SJ, Olivotto I, Russell MW, Godown J, Chiu M, German P, Heitner SB, Jacoby DL, Kupfer S, Lutz J, Maharao N, Malik FI, Melloni C, Nieto Morales PF, Simkins T, Wei J, Ho CY; CEDAR-HCM Investigators. Efficacy and Safety of Aficamten in Children and Adolescents With Obstructive Hypertrophic Cardiomyopathy: Study Design and Rationale of CEDAR-HCM. Circ Heart Fail. 2025 Dec 5:e013418. doi: 10.1161/CIRCHEARTFAILURE.125.013418. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).', 'detailedDescription': 'The overall objective of the trial is to determine the efficacy, safety, and tolerability of administration of aficamten in adolescents (12 to \\< 18 years old) and children (6 to \\< 12 years old) with symptomatic oHCM. Adolescents and children will be studied in a staged approach involving established favorable pharmacodynamic and safety profiles of aficamten in adolescents followed by further pharmacokinetic modeling to inform the dosing regimen in children. Only the 12 to \\<18 years old cohort is currently open for enrollment.\n\nThe trial will consist of 3 periods:\n\n1. Period 1 is the randomized, double-blind, placebo-controlled treatment period that will assess the efficacy, safety and tolerability of aficamten in pediatric participants. Duration: 12 weeks.\n2. Period 2 is the open-label extension trial that will assess the long-term safety of aficamten in pediatric participants, and further assess efficacy and tolerability. Duration: 52 weeks.\n3. Period 3 is the long-term extension trial that will assess the long-term safety of aficamten in pediatric participants, and further assess efficacy and tolerability. Duration: 144 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Period 1: Treatment Period\n\n * Males and females between 12 and \\< 18 years of age at screening and at Day 1.\n * Body weight ≥ 45 kg for the initial cohort and then body weight ≥ 35 kg after at least 10 participants in the initial cohort have undergone dose titration up to Week 4 without observed events of LVEF \\< 50% at the starting dose of 5 mg qd.\n * Core laboratory confirmation of the following oHCM echocardiographic criteria at screening:\n* Left ventricular (LV) hypertrophy with nondilated LV chamber in the absence of other cardiac disease.\n* LV end-diastolic wall thickness that meets a threshold of:\n\n * Z-score \\> 2.5 in the absence of family history OR\n * Z-score \\> 2 in the presence of positive family history or positive genetic test.\n* LVEF ≥ 60% AND Valsalva LVOT-G ≥ 50 mmHg.\n\n * oHCM of sarcomeric origin confirmed by genetic testing or, if unable to confirm by genetic testing, oHCM of sarcomeric origin may be presumed in the absence of history of metabolic disorders, mitochondrial cardiomyopathies, neuromuscular disease, malformation syndromes, infiltrative diseases/inflammation, and endocrine disorders (such as Fabry's disease, Noonan syndrome with left ventricular hypertrophy, and amyloid-cardiomyopathy).\n * New York Heart Association (NYHA) Class ≥ II at screening.\n * Adequate acoustic windows for echocardiography.\n * Participants on beta blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for more than 4 weeks prior to randomization.\n* Period 2: Open-Label Extension\n\n * Completed Period 1. If unable to complete Period 1 due to circumstances not related to compliance or safety, the Medical Monitor may review and determine eligibility.\n * LVEF ≥ 55% after washout.\n* Period 3: Long-term Extension • Completed Period 2.\n\nExclusion Criteria:\n\n* Period 1: Treatment Period\n\nAny of the following criteria will exclude potential participants from the trial:\n\n* Significant valvular heart disease.\n\n * Moderate or severe valvular aortic stenosis or fixed subaortic obstruction.\n * Mitral regurgitation that is greater than mild in severity and not due to systolic anterior motion of the mitral valve (per judgment of Principal Investigator or designee).\n * Evidence of fixed left-sided obstruction (eg, subaortic membrane, aortic valve stenosis, or coarctation of the aorta).\n* History of LV systolic dysfunction (LVEF \\< 45%) or stress cardiomyopathy at any time during their clinical course.\n* History of congenital heart disease other than oHCM (may be enrolled if not hemodynamically significant in the judgement of the Principal Investigator and study Medical Monitor).\n* Has been treated with SRT (surgical myectomy or percutaneous alcohol septal ablation) within the preceding 6 months or has plans for either treatment during the trial period.\n* History of paroxysmal or persistent atrial fibrillation or atrial flutter.\n* History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia within 3 months prior to screening.\n* History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the Principal Investigator (or designee) or the Medical Monitor, would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.\n* Current or previous use of drugs known to cause cardiomyopathy (eg, anthracyclines, monoclonal antibodies \\[trastuzumab\\], alkylating agents \\[cyclophosphamide\\], and tyrosine kinase inhibitors \\[sunitinib and imatinib\\]).\n* Currently participating in another investigational device or drug trial or received an investigational device or drug \\< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening.\n* Implantable cardioverter defibrillator (ICD) implantation within 6 weeks of screening or planned ICD implantation during the trial period.\n* Has received prior treatment with aficamten or mavacamten.\n* Currently listed for heart transplantation or anticipated to be listed for heart transplantation in the next 12 months."}, 'identificationModule': {'nctId': 'NCT06412666', 'acronym': 'CEDAR-HCM', 'briefTitle': 'A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cytokinetics'}, 'officialTitle': 'A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled and Open-Label Extension Trial to Evaluate the Efficacy and Safety of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'CY 6023'}, 'secondaryIdInfos': [{'id': '2024-511377-30-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aficamten', 'description': 'Participants in this arm will receive a single daily oral dose of aficamten with dose levels (5 mg to 20 mg) guided by echocardiography assessments, for 12 weeks during the double-blinded period, for another 52 weeks during the open-label extension period, and for an additional 144 weeks during the long-term extension period.', 'interventionNames': ['Drug: Aficamten']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive a single daily oral dose of placebo for 12 weeks during the double-blinded period and then will receive aficamten for 52 weeks during the open-label extension period, followed by an additional 144 weeks of aficamten during the long-term extension period.', 'interventionNames': ['Drug: Aficamten', 'Drug: Placebo']}], 'interventions': [{'name': 'Aficamten', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Aficamten', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Papez', 'role': 'CONTACT'}, {'name': 'Andrew Papez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Kantor', 'role': 'CONTACT'}, {'name': 'Paul Kantor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nancy Halnon', 'role': 'CONTACT'}, {'name': 'Nancy Halnon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, Los Angeles (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Othman Aljohani', 'role': 'CONTACT'}, {'name': 'Othman Aljohani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "UCSF Benioff Children's Hospital", 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Nakano', 'role': 'CONTACT'}, {'name': 'Stephanie Nakano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sairah Khan', 'role': 'CONTACT'}, {'name': 'Sairah Khan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's National Hospital", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ronald Kanter', 'role': 'CONTACT'}, {'name': 'Ronald Kanter', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Defne Magnetta', 'role': 'CONTACT'}, {'name': 'Defne Magnetta', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ann & Robert H. Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gary Beasley', 'role': 'CONTACT'}, {'name': 'Gary Beasley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70018', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tamara Bradford', 'role': 'CONTACT'}, {'name': 'Tamara Bradford', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Russell', 'role': 'CONTACT'}, {'name': 'Mark Russell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Swati Sehgal', 'role': 'CONTACT'}, {'name': 'Swati Sehgal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Ameduri', 'role': 'CONTACT'}, {'name': 'Rebecca Ameduri', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian Birnbaum', 'role': 'CONTACT'}, {'name': 'Brian Birnbaum', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Cole', 'role': 'CONTACT'}, {'name': 'Jason Cole', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Martinez', 'role': 'CONTACT'}, {'name': 'Matthew Martinez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irene Lytrivi', 'role': 'CONTACT'}, {'name': 'Irene Lytrivi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYP/Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daphne Hsu', 'role': 'CONTACT'}, {'name': 'Daphne Hsu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital at Montefiore", 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27701', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kevin Hill', 'role': 'CONTACT'}, {'name': 'Kevin Hill', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Clinical Research Institute', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seshadri Balaji', 'role': 'CONTACT'}, {'name': 'Seshadri Balaji', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Humera Ahmed', 'role': 'CONTACT'}, {'name': 'Humera Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kaitlin Ryan', 'role': 'CONTACT'}, {'name': 'Kaitlin Ryan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "LeBonheur Children's Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37235', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aarti Dalal', 'role': 'CONTACT'}, {'name': 'Aarti Dalal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chesney Castleberry', 'role': 'CONTACT'}, {'name': 'Chesney Castleberry', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Dell Children's Hospital", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nathanya Baez-Hernandez', 'role': 'CONTACT'}, {'name': 'Nathanya Baez-Hernandez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UT Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexander Raskin', 'role': 'CONTACT'}, {'name': 'Alexander Raskin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1E8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Bhavikkumar Langanecha', 'role': 'CONTACT'}, {'name': 'Bhavikkumar Langanecha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hospital for Sick Children (SickKids)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Iacopo Olivotto', 'role': 'CONTACT'}, {'name': 'Iacopo Olivotto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Careggi University Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Kagoshima', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yumiko Ninomiya', 'role': 'CONTACT'}, {'name': 'Yumiko Ninomiya', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NHO Kagoshima Medical Center', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Osaka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Jun Narita', 'role': 'CONTACT'}, {'name': 'Jun Narita', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Osaka Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sagamihara', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoichiro Hirata', 'role': 'CONTACT'}, {'name': 'Yoichiro Hirata', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kitasato University Hospital', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Suita', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenichi Kurosaki', 'role': 'CONTACT'}, {'name': 'Kenichi Kurosaki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hideo Fukunaga', 'role': 'CONTACT'}, {'name': 'Hideo Fukunaga', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'A Coruña', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Fernando R Nunez', 'role': 'CONTACT'}, {'name': 'Fernando R Nunez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unidad de Cardiología Infantil; Hospital Universitario da Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Barcelona', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Georgia Sarquella Brugada', 'role': 'CONTACT'}, {'name': 'Georgia Sarquella Brugada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sant Joan de Deu', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Bernadette Khodaghalian', 'role': 'CONTACT'}, {'name': 'Bernadette Khodaghalian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Alder Hey Children's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SW3 6NP', 'city': 'London', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Andres Rico-Armada', 'role': 'CONTACT'}, {'name': 'Andres Rico-Armada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Evelina Children's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1N 3BH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Juan P Kaski', 'role': 'CONTACT'}, {'name': 'Juan P Kaski', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Cytokinetics MD', 'role': 'CONTACT', 'email': 'medicalaffairs@cytokinetics.com', 'phone': '6506242929'}], 'overallOfficials': [{'name': 'Cytokinetics MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cytokinetics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cytokinetics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}