Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03057002
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2017-01-10
Brief Title:
UTSW HP 13-C Pyruvate Injection in HCM
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Detection of Myocardial Metabolic Changes in Patients With Cardiomyopathy Using Hyperpolarized Carbon 13 Magnetic Resonance Spectroscopic Imaging
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPHCM
Brief Summary:
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 1-13Cpyruvate flux
Detailed Description:
To measure the regional myocardial 1-13Clactate to 13Cbicarbonate 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
Heart 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
Additionally 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
Heart 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
Additionally 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None