Effect of a PPAR-Alpha Agonist on the Age Related Changes in Myocardial Metabolism and Mechanical Function (PPAR)
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|ClinicalTrials.gov Identifier: NCT00627653|
Recruitment Status : Unknown
Verified February 2009 by National Institute on Aging (NIA).
Recruitment status was: Active, not recruiting
First Posted : March 3, 2008
Last Update Posted : February 19, 2009
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases||Drug: fenofibrate|
In older Americans, cardiovascular disease is the leading cause of death and disability. It has been shown recently that with aging the human heart exhibits a decline in myocardial fatty acid utilization (MFAU) and oxidation (MFAO) and that these metabolic changes are paralleled by a decline in mechanical function. It has also been shown that peroxisome proliferator activated receptor alpha (PPAR-alpha) activates the expression of the genes encoding enzymes involved in mitochondrial fatty acid transport and oxidation. There is both indirect and direct evidence that PPAR-alpha-mediated responses decrease with age. Consequently, we hypothesize that changes in fatty acid in the aging heart may be mediated, at least in part, via a decline in PPAR-alpha-mediated responses. Thus, administration of a PPAR-alpha agonist to older humans will result in a shift in cardiac fatty acid metabolism to that more closely seen in younger humans and this shift will be paralleled by an improvement in cardiac mechanical function.
To prove or disprove this hypothesis, we will determine, in aged and young healthy volunteers, whether stimulation of PPAR-alpha using the partial agonist, fenofibrate, shifts myocardial substrate utilization by increasing MFAU and MFAO, and whether these changes are associated with an increase in left ventricular function. Study participants will have 4 clinic visits, each lasting approximately 5 hours.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||PET (Positron Emission Tomography) Detection of the Effects of Aging on the Human Heart (Aim #2 Effect of a PPAR-Alpha Agonist on the Age Related Changes in Myocardial Metabolism and Mechanical Function)|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
148mg daily for 30 days
Other Name: Lofibra; TriCor
- Shift in Myocardial substrate utilization in aging hearts [ Time Frame: After the day-30 PET scan ]
- Increased left ventricular function due to shift in substrate use in aging hearts [ Time Frame: After the day-30 PET scan ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627653
|United States, Missouri|
|Washington University School of Medicine|
|St Louis, Missouri, United States, 63110|
|Principal Investigator:||Robert Gropler, MD||Washington University School of Medicine|