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Effect of a PPAR-Alpha Agonist on the Age Related Changes in Myocardial Metabolism and Mechanical Function (PPAR)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by National Institute on Aging (NIA).
Recruitment status was:  Active, not recruiting
Information provided by:
National Institute on Aging (NIA) Identifier:
First received: February 28, 2008
Last updated: February 18, 2009
Last verified: February 2009
The purpose of this study is to determine if treatment with a drug called fenofibrate, which is a PPAR-alpha agonist and controls how the heart metabolizes fats, will reverse the age-related decline in cardiac fat metabolism and mechanical function.

Condition Intervention
Cardiovascular Diseases
Drug: fenofibrate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Shift in Myocardial substrate utilization in aging hearts [ Time Frame: After the day-30 PET scan ]

Secondary Outcome Measures:
  • Increased left ventricular function due to shift in substrate use in aging hearts [ Time Frame: After the day-30 PET scan ]

Estimated Enrollment: 60
Study Start Date: October 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: fenofibrate
148mg daily for 30 days
Other Name: Lofibra; TriCor

Detailed Description:

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.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Aged 60-75 or 21-35
  • Normal glucose tolerance test
  • Normal plasma fasting lipid panel (fasting total cholesterol less than 220 mg/dL)
  • Normal rest/stress echocardiogram
  • BMI (body mass index) less than 30 kg/m2
  • Must be sedentary (active, but do not engage in regular exercise or jobs that require strenuous exertion)

Exclusion Criteria:

  • Coronary artery disease
  • High blood pressure
  • Current smoker
  • Diabetes mellitus
  • Cardiovascular disease (signs and symptoms of any kind)
  • Pregnant or breastfeeding
  Contacts and Locations
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Please refer to this study by its identifier: NCT00627653

United States, Missouri
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: Robert Gropler, MD Washington University School of Medicine