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

NCT00627653 | Unknown

• 2 other identifiers: AG0093ROI AG15466
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Keywords

PPAR; PET study; heart metabolism

Outcome Measures

Primary Outcomes (1)

• Shift in Myocardial substrate utilization in aging hearts

  After the day-30 PET scan

Secondary Outcomes (1)

• Increased left ventricular function due to shift in substrate use in aging hearts

  After the day-30 PET scan

Study Arms (1)

1

EXPERIMENTAL

Drug: fenofibrate

Interventions

fenofibrate DRUG

148mg daily for 30 days

Also known as: Lofibra; TriCor

1

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Coronary artery disease
• High blood pressure
• Current smoker
• Diabetes mellitus
• Cardiovascular disease (signs and symptoms of any kind)
• Pregnant or breastfeeding

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Ogawa T, Spina RJ, Martin WH 3rd, Kohrt WM, Schechtman KB, Holloszy JO, Ehsani AA. Effects of aging, sex, and physical training on cardiovascular responses to exercise. Circulation. 1992 Aug;86(2):494-503. doi: 10.1161/01.cir.86.2.494.

  PMID: 1638717 BACKGROUND

• Coughlin SS, Neaton JD, Sengupta A, Kuller LH. Predictors of mortality from idiopathic dilated cardiomyopathy in 356,222 men screened for the Multiple Risk Factor Intervention Trial. Am J Epidemiol. 1994 Jan 15;139(2):166-72. doi: 10.1093/oxfordjournals.aje.a116978.

  PMID: 8296783 BACKGROUND

• Haldeman GA, Croft JB, Giles WH, Rashidee A. Hospitalization of patients with heart failure: National Hospital Discharge Survey, 1985 to 1995. Am Heart J. 1999 Feb;137(2):352-60. doi: 10.1053/hj.1999.v137.95495.

  PMID: 9924171 BACKGROUND

• Olivetti G, Melissari M, Capasso JM, Anversa P. Cardiomyopathy of the aging human heart. Myocyte loss and reactive cellular hypertrophy. Circ Res. 1991 Jun;68(6):1560-8. doi: 10.1161/01.res.68.6.1560.

  PMID: 2036710 BACKGROUND

• Kannel WB, Belanger AJ. Epidemiology of heart failure. Am Heart J. 1991 Mar;121(3 Pt 1):951-7. doi: 10.1016/0002-8703(91)90225-7.

  PMID: 2000773 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Study Officials

• Robert Gropler, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 3, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 19, 2009

Record last verified: 2009-02

Locations

US (1)