[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100258799":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":31,"centralContacts":36,"locations":43,"responsibleParty":70,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":30,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Healthy Volunteers","Arm 1\n\n* Group 1A: control male volunteers between 19 and 50 years of age.\n* Group 1B: control female volunteers between 19 and 50 years of age.\n* Group 1C: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice\n* Group 1D: control male volunteers between 19 and 50 years of age.\n* Group 1E: control female volunteers between 19 and 50 years of age.\n* Group 1F: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice",[12],"Drug: Hyperpolarized (13) Pyruvate Injection",{"label":14,"type":6,"description":15,"interventionNames":16},"Hypertension Hypertrophy Volunteers","Arm 2\n\n* Group 2A: patients aged 30 to 75 with hypertension and hypertrophy\n* Group 2B: patients aged 30 to 75 with non-obstructive hypertrophic cardiomyopathy (HCM).\n* Group 2C: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF.\n* Group 2D: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents.\n* Group 2E: patients aged 30 to 75 with hypertrophy\n* Group 2F: patients aged 30 to 75 with hypertrophic cardiomyopathy (HCM).\n* Group 2G: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF.\n* Group 2H: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents.",[12,17],"Drug: Gadolinium",[19,26],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Hyperpolarized (13) Pyruvate Injection","MRI with Hyperpolarized Pyruvate (13) Injection",[9,14],[25],"Hyperpolarized Pyruvate (13) Injection",{"type":20,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Gadolinium","MRI with Gadolinium",[14],null,[32],{"name":33,"affiliation":34,"role":35},"Charles Cunningham, PhD","Sunnybrook Research Institute","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Norberto Garcia","CONTACT","4164806100","683655","norberto.garcia@sunnybrook.ca",[44,60],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Toronto","Ontario","M4N 3M5","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58,59],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},{"name":33,"role":35,"phone":30,"phoneExt":30,"email":30},{"facility":61,"status":62,"city":46,"state":47,"zip":30,"country":49,"countryCode":50,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"St. Michael's Hospital","NOT_YET_RECRUITING",{"type":52,"coordinates":64},[54,55],{"lat":55,"lon":54},[67,69],{"name":68,"role":39,"phone":30,"phoneExt":30,"email":30},"Kim Connelly, MBBS PhD FRCP",{"name":68,"role":35,"phone":30,"phoneExt":30,"email":30},{"type":71,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100258799","phase-1-metabolic-imaging-of-the-heart-using-hyperpolarized-13c-pyruvate-injection-100258799",false,"NCT02648009","Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection","Inclusion Criteria\n\n* Written consent\n* Age: 19 to 50 in Arm 1, 30 to 75 in Arm 2\n* Group 2A and 2E participants have left-ventricular hypertrophy\n* Group 2B and 2F participants have diagnosed hypertrophic cardiomyopathy\n* Group 2C and 2G participants are stable outpatients with NYHA class 1-3 heart failure with evidence of elevated LV mass (LVH), irrespective of LVEF.\n* Group 2D and 2H participants are stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents\n\nExclusion Criteria\n\n* Contraindications to MRI or MRI contrast agents\n* Hemoglobin ≤ 9.0 gm\u002FdL (only Group 2 participants)\n* Glomerular filtration rate (based on MDRD Equation) \\\u003C 30 ml\u002Fmin\u002F1.73m2 (only Group 2 participants)\n* Any condition leading to a life expectancy \\\u003C1 year\n* Medically diagnosed claustrophobia\n* Have received, or are scheduled to receive, another investigational medicinal product from 1 month prior to 1 month after inclusion in this study\n* BMI of less than 18.5 or greater than 32\n* Group 1: medically diagnosed heart disease",true,"ALL","19 Years","75 Years",{"count":83,"type":84},112,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the health care system's most expensive diagnoses. Despite major advances in medicine, the mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI) is used for non-invasive imaging of the cardiovascular system to enable the structure and anatomy of the organ to be visualized. However, current MRI methods have limitations when assessing and aiding in the management of CHF. A new imaging method has recently been developed that is showing great promise as a tool in the management of patients with CHF. Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method. DNP-dissolution results in an intravenous contrast agent that is \"hyperpolarized\", producing a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13 labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods.",[90,91],"Hypertension","Hypertrophy","2026-01-27",{"date":94,"type":95},"2026-01-29","ACTUAL",{"date":97,"type":30},"2016-04",{"date":99,"type":84},"2027-04",{"name":5,"class":6},2]