Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06174220
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019571', 'term': 'Arrhythmogenic Right Ventricular Dysplasia'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520571', 'term': 'tideglusib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized in a 1:1 ratio using an automated central, web-based system within 30 days of completing their baseline Holter. Randomization will be stratified by TMEM43-p.S358L variant status.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-08', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PVC burden', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in mean PVC count per 24 hours on 7-day Holter'}], 'secondaryOutcomes': [{'measure': 'Ventricular strain', 'timeFrame': 'Baseline and 6 months', 'description': 'Change in ventricular strain on echocardiography'}, {'measure': 'Implantable cardioverter-defibrillator (ICD) therapies', 'timeFrame': 'Baseline and 6 months', 'description': 'Number of ICD therapies (shock or anti-tachycardia pacing)'}, {'measure': 'Sustained ventricular tachycardia (VT) events', 'timeFrame': 'Baseline and 6 months', 'description': 'Number of sustained VT events (defined as symptomatic or duration \\> 30 seconds and \\> 100bpm)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sudden cardiac death, ventricular cardiomyopathy, genetics, arrhythmia'], 'conditions': ['Arrhythmogenic Cardiomyopathy', 'Arrhythmogenic Right Ventricular Cardiomyopathy']}, 'referencesModule': {'references': [{'pmid': '35450611', 'type': 'BACKGROUND', 'citation': 'Krahn AD, Wilde AAM, Calkins H, La Gerche A, Cadrin-Tourigny J, Roberts JD, Han HC. Arrhythmogenic Right Ventricular Cardiomyopathy. JACC Clin Electrophysiol. 2022 Apr;8(4):533-553. doi: 10.1016/j.jacep.2021.12.002.'}, {'pmid': '24920660', 'type': 'BACKGROUND', 'citation': 'Asimaki A, Kapoor S, Plovie E, Karin Arndt A, Adams E, Liu Z, James CA, Judge DP, Calkins H, Churko J, Wu JC, MacRae CA, Kleber AG, Saffitz JE. Identification of a new modulator of the intercalated disc in a zebrafish model of arrhythmogenic cardiomyopathy. Sci Transl Med. 2014 Jun 11;6(240):240ra74. doi: 10.1126/scitranslmed.3008008.'}, {'pmid': '27170944', 'type': 'BACKGROUND', 'citation': 'Chelko SP, Asimaki A, Andersen P, Bedja D, Amat-Alarcon N, DeMazumder D, Jasti R, MacRae CA, Leber R, Kleber AG, Saffitz JE, Judge DP. Central role for GSK3beta in the pathogenesis of arrhythmogenic cardiomyopathy. JCI Insight. 2016 Apr 21;1(5):e85923. doi: 10.1172/jci.insight.85923.'}, {'pmid': '31264976', 'type': 'BACKGROUND', 'citation': 'Roberts JD, Murphy NP, Hamilton RM, Lubbers ER, James CA, Kline CF, Gollob MH, Krahn AD, Sturm AC, Musa H, El-Refaey M, Koenig S, Aneq MA, Hoorntje ET, Graw SL, Davies RW, Rafiq MA, Koopmann TT, Aafaqi S, Fatah M, Chiasson DA, Taylor MR, Simmons SL, Han M, van Opbergen CJ, Wold LE, Sinagra G, Mittal K, Tichnell C, Murray B, Codima A, Nazer B, Nguyen DT, Marcus FI, Sobriera N, Lodder EM, van den Berg MP, Spears DA, Robinson JF, Ursell PC, Green AK, Skanes AC, Tang AS, Gardner MJ, Hegele RA, van Veen TA, Wilde AA, Healey JS, Janssen PM, Mestroni L, van Tintelen JP, Calkins H, Judge DP, Hund TJ, Scheinman MM, Mohler PJ. Ankyrin-B dysfunction predisposes to arrhythmogenic cardiomyopathy and is amenable to therapy. J Clin Invest. 2019 Jul 2;129(8):3171-3184. doi: 10.1172/JCI125538. eCollection 2019 Jul 2.'}, {'pmid': '31567019', 'type': 'BACKGROUND', 'citation': 'Padron-Barthe L, Villalba-Orero M, Gomez-Salinero JM, Dominguez F, Roman M, Larrasa-Alonso J, Ortiz-Sanchez P, Martinez F, Lopez-Olaneta M, Bonzon-Kulichenko E, Vazquez J, Marti-Gomez C, Santiago DJ, Prados B, Giovinazzo G, Gomez-Gaviro MV, Priori S, Garcia-Pavia P, Lara-Pezzi E. Severe Cardiac Dysfunction and Death Caused by Arrhythmogenic Right Ventricular Cardiomyopathy Type 5 Are Improved by Inhibition of Glycogen Synthase Kinase-3beta. Circulation. 2019 Oct;140(14):1188-1204. doi: 10.1161/CIRCULATIONAHA.119.040366. Epub 2019 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The TaRGET study is a multi-centre, prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the potential therapeutic efficacy of tideglusib, a glycogen synthase kinase-3 β inhibitor, in genotype positive arrhythmogenic cardiomyopathy.', 'detailedDescription': 'Arrhythmogenic cardiomyopathy (ACM) is a heritable form of structural heart disease characterized by myocardial fibrosis that confers vulnerability to malignant ventricular arrhythmias and sudden cardiac death (SCD). A subgroup of cases preferentially involves the right ventricle and is termed arrhythmogenic right ventricular cardiomyopathy (ARVC). Although an increasingly diverse set of genes have been implicated in ACM, its most prominent genetic culprits are constituents of the desmosome, a specialized cellular structure within the intercalated disc that mediates intercellular adhesion. An additional ACM genetic subtype develops secondary to the TMEM43-p.S358L variant and is associated with an aggressive clinical phenotype, particularly among males.\n\nDespite dramatic progress in unravelling the genetic underpinnings of ACM, insight into its pathophysiology remains modest. A lack of understanding of its operative biological pathways has rendered development of tailored treatments challenging, leading to approaches to medical therapy being largely adopted from those utilized for more common forms of cardiomyopathy. An implantable cardioverter defibrillator (ICD) is recommended for prevention of SCD for all ACM patients considered high risk for malignant ventricular arrhythmias, however does not address its underlying pathophysiology. Subsequent prevention of painful ICD shocks for ventricular tachycardia often requires interventions that may carry modest efficacy and significant risks for adverse events, including anti-arrhythmic drugs and invasive combined endo- and epicardial catheter ablation procedures.\n\nIn 2014, a high-throughput screen of a library of bioactive compounds against a zebrafish model of ACM identified a small molecule classified as a glycogen synthase kinase-3 (GSK3) inhibitor that successfully prevented and rescued the phenotype, findings that have subsequently been reproduced in a series of ACM murine models. GSK3 is an enzyme that modulates the activity of a broad spectrum of intracellular signaling pathways, including the canonical Wnt/β-catenin pathway, whose suppression has been suggested to exert an important role in ACM pathogenesis.\n\nTideglusib is an oral GSK3β inhibitor with an established safety profile in humans. Driven by promising findings observed for tideglusib in ACM mouse models, we now seek to evaluate its potential efficacy in a randomized clinical trial involving genotype positive ACM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP\\*) rare variant OR the TMEM43-p.S358L variant\n\n \\*JUP carriers must be homozygous or compound heterozygous\n* Mean ≥ 500 PVCs per 24 hours on a baseline screening 7-day Holter monitor\n* Clinical ACM diagnosis or recognition of genetic carrier status for ≥ 6 months prior to screening\n\nExclusion Criteria:\n\n* NYHA class IV heart failure\n* Ventricular scar secondary to coronary artery disease\n* Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in the 3 months prior to screening\n* Any potentially harmful chronic liver disease\n* ALT value \\> 2X the upper limit of the normal reference range at Screening\n* Total bilirubin value greater than the upper limit of the normal reference range at Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's syndrome, total bilirubin value greater than 2-fold the upper limit of the normal reference range at Screening.\n* A history of alcohol or illicit substance use disorders\n* Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir\n* Serum creatinine \\> 150 micromole/L or creatinine clearance ≤ 60 mL/min (according to Cockcroft-Gault formula) at Screening\n* Pregnant at time of enrollment and women of childbearing age who do not use a highly effective form of contraception\n* Males, engaged in sexual relations with a female of child-bearing potential, not using an acceptable contraceptive method if not surgically sterile\n* Patients unwilling to provide informed consent or comply with follow-up\n* Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry\n* Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin"}, 'identificationModule': {'nctId': 'NCT06174220', 'acronym': 'TaRGET', 'briefTitle': 'Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'PHRI.TaRGET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tideglusib', 'description': 'Randomization to Tideglusib 1g po daily or matching placebo', 'interventionNames': ['Drug: Tideglusib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomization to matching placebo 1g po daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tideglusib', 'type': 'DRUG', 'description': 'Tideglusib 1g po daily', 'armGroupLabels': ['Tideglusib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo 1g po daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Erkan Ilhan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Patrick Champagne, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Thomas M Roston, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Zachary Laksman, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrew D Krahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gnalini Sathananthan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8Z 0B9', 'city': 'Victoria', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'May Woodburn', 'role': 'CONTACT', 'email': 'mwoodburn@catrials.org', 'phone': '250-595-0400'}, {'name': 'Martin van Zyl, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karan Shetty, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Victoria Cardiac Arrhythmia Trials Inc.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephen Duffett, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sean Connors, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kathy Hodgkinson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ashar Pirzada, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Health Sciences Centre', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'David Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ciorsti MacIntyre, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Belliveau, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Queen Elizabeth II Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeff Healey', 'role': 'CONTACT', 'email': 'jeff.healey@phri.ca', 'phone': '905-527-0271', 'phoneExt': '40312'}, {'name': 'Jeff S Healey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Javier Ganame, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'William F McIntyre, MD PhD FRCPC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Chris Simpson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Amar Thakrar, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sara El-Richani', 'role': 'CONTACT', 'email': 'lhrp.research@lhsc.on.ca', 'phone': '519-685-8500', 'phoneExt': '36808'}, {'name': 'Habib R Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mouhannad Sadek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Molly Thangaroopan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Newmarket Electrophysiologist Research Group 'NERG'", 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Simon Hansom, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Green, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lawrence Lau, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M1E 4B9', 'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Emily Magimaidoss', 'role': 'CONTACT', 'email': 'emagimaidoss@hearthealthinstitute.net', 'phone': '416-281-9499', 'phoneExt': '3015'}, {'name': 'Bhavanesh Makanjee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Derek Yung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Natalie Ho, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Heart Health Institute Research Inc', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christopher Cheung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Idan Roifman, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Paul Angaran, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Geraldine Ong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeremie Cortial', 'role': 'CONTACT', 'email': 'jeremie.cortial@icm-mhi.org', 'phone': '514-376-3330', 'phoneExt': '2293'}, {'name': 'Julia Cadrin-Tourigny, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rafik Tadros, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marie Chaix, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jacqueline Joza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Chetrit, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Leila Laroussi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alexios Hadjis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nadia Boule-Laghlazi, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hopital du Sacré-Coeur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dr. Christian Steinberg', 'role': 'CONTACT', 'email': 'christian.steinberg@criucpq.ulaval.ca', 'phone': '418-656-8711'}, {'name': 'Christian Steinberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jonathan Beaudoin, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Institute of Cardiology and Pneumology of Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Jason D Roberts, MD MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University and Population Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Population Health Research Institute', 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'AMO Pharma', 'class': 'UNKNOWN'}, {'name': 'Hearts in Rhythm Organization (HiRO)', 'class': 'UNKNOWN'}, {'name': 'Canadian SADS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}