Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-12 @ 4:55 AM
Study NCT ID:
NCT03057002
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UTSW HP [13-C] Pyruvate Injection in HCM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}, {'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], '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'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperpolarized [1-13C]pyruvate flux', 'timeFrame': 'Screening (Baseline) and 1 day of Study Visit', 'description': 'Measurement of change in myocardial hyperpolarized \\[1-13C\\]pyruvate flux during Magnetic Resonance Spectroscopic Imaging.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiomyopathy, Hypertrophic', 'Dilated Cardiomyopathy', 'Duchenne Muscular Dystrophy', 'Cardiac Sarcoidosis', 'Becker Muscular Dystrophy', 'Heart Failure With Preserved Ejection Fraction', 'Heart Failure With Reduced Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'The study objective is to identify the earliest changes in energy substrate metabolism in patients with cardiomyopathies (CMP). To achieve this objective, we plan first to test the hypothesis that patients with CMP present focal alterations in myocardial hyperpolarized \\[1-13C\\]pyruvate flux.', 'detailedDescription': 'To measure the regional myocardial \\[1-13C\\]lactate to \\[13C\\]bicarbonate ratio as an index of mitochondrial oxidation and glycolysis coupling in the heart. Advanced cardiac MRI will be used to characterize cardiac morphology, function, myocardial blood flow and fibrosis.\n\nHeart failure is a major source of morbidity and mortality in the United States. Multiple studies have demonstrated that development of heart failure is related to alteration in cardiac metabolism. Specifically, such changes include a shift from fatty acid oxidation to increased glucose utilization as energy source, with uncoupling of glycolysis and mitochondrial oxidation at the level of the pyruvate dehydrogenase complex. In human subject who were referred for LVAD placement, excised heart muscle samples exhibited significant increase in expression of pyruvate kinase M2 (PKM2) compared to subjects with normal LV function.\n\nAdditionally, mechanical unloading decreased PKM2 expression suggesting a correlation between pyruvate utilization and severity of heart failure. Such changes metabolic alterations appear to precede the actual structural changes and might be a possible target for future therapies, although the timeline of such changes remains to be elucidated. Currently, it is unknown whether different types of CMP have different metabolic signatures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '5 Cardiomyopathy (CMP) Patients and 5 Healthy Controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Control Subjects:\n\n* Subjects who are 18.\n* Subjects who have the ability to understand and the willingness to sign a written informed consent.\n* While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.\n* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInclusion Criteria for participants with Cardiomyopathy:\n\n* Subjects who are 18.\n* Subjects who have the ability to understand and the willingness to sign a written informed consent.\n* While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.\n* Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nExclusion criteria:\n\n* Subjects who are receiving any other investigational agents.\n* Intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled chronic diseases such as hypertension, lung disease, liver disease, kidney disease, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Subjects who are taking thyroid hormone replacements, have a history of alcohol abuse or illicit drug use.\n* Subjects who have contraindication to contrast enhanced MRI examination.\n\nContraindications to MRI examinations include:\n\n* Medically unstable\n* Acute Heart failure\n* Severe LVOT obstruction\n* Unstable angina\n* Child bearing\n* Lactating\n* Any contraindication per MRI Screening Form including\n* Implants contraindicated at 3Tesla, pacemakers\n* Implantable Cardioverter Defibrillator (ICD)\n* Claustrophobia\n* Since each subject is receiving a gadolinium based contrast agent intravenously:\n* eGFR ≤ 30 mL/min/1.73m2\n* Sickle cell disease\n* Hemolytic anemia'}, 'identificationModule': {'nctId': 'NCT03057002', 'acronym': 'HPHCM', 'briefTitle': 'UTSW HP [13-C] Pyruvate Injection in HCM', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Detection of Myocardial Metabolic Changes in Patients With Cardiomyopathy Using Hyperpolarized Carbon 13 Magnetic Resonance Spectroscopic Imaging', 'orgStudyIdInfo': {'id': 'STU 102016-046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiomyopathy', 'description': 'Patients with Cardiomyopathy will be observed for myocardial hyperpolarized 13C-pyruvate flux during magnetic resonance spectroscopic imaging.', 'interventionNames': ['Diagnostic Test: Hyperpolarized 13C-Pyruvate']}, {'label': 'Control', 'description': 'Healthy control subjects will be observed for myocardial hyperpolarized 13C-pyruvate flux during magnetic resonance spectroscopic imaging.', 'interventionNames': ['Diagnostic Test: Hyperpolarized 13C-Pyruvate']}], 'interventions': [{'name': 'Hyperpolarized 13C-Pyruvate', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['HP [1-13C]pyruvate'], 'description': 'All subjects will be observed for myocardial hyperpolarized \\[1-13C\\]pyruvate flux during magnetic resonance spectroscopic imaging.', 'armGroupLabels': ['Cardiomyopathy', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center - Advanced Imaging Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Vlad G Zaha, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Imaging Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Vlad Zaha', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}