Clinical trial NCT00776035: Sex and Obesity: Effects on Heart Failure Study
Official title: Sex and Obesity Effects on Myocardial Blood Flow and Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Heart Failure
Keywords: Obesity
Heart
Failure
PET (positron emission tomography)
radiation
metabolism
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2008-10-20
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with heart failure were recruited for this study from the Washington University in St. Louis VO2 peak database, which consisted of participants who had been referred to and completed VO2 testing in the Cardiac Rehabilitation-run laboratory since 1998.

Brief summary: Sex has a major impact on myocardial metabolism and blood flow. In those without heart failure men's hearts tend to use proportionally more glucose and women's hearts use more fat and have higher blood flow.

Obesity is a major risk factor for Heart Failure. In those without heart failure, increasing body mass index is predictive of increased blood flow and fatty acid metabolism in women, but not men.

To measure blood flow and metabolism we used radioactive materials and a PET (positron emission Tomography) scan to study the blood flow and substrate metabolism of the heart.

Hypotheses: 1) Women with heart failure with reduced ejection fraction (HFrEF) will have higher levels of heart blood flow and fatty acid metabolism and lower glucose metabolism rates than men with HFrEF. A secondary Aim was to test the hypothesis that body mass index (BMI), a measure of obesity, correlated with myocardial blood flow and myocardial metabolism measures in patients with HFrEF.


Eligibility criteria: Inclusion criteria

* Heart failure (HF) and a systolic ejection fraction \<45% per a recent echocardiogram report)
* Nonischemic HF New York Heart Association Class II-III
* Ambulatory
* Able to give informed consent
* On a stable medical regimen including the standard-of-care HF medications (i.e., a beta-blocker, ACE-inhibitor or angiotensin receptor blocker \[ARB\])

Exclusion criteria

* Participants who were pregnant or lactating
* Actively losing weight
* Nonsedentary (performing aerobic exercise \> 30 minutes x 3 times/week)
* Those who have more than Class I hypertension
* Those who require alterations in beta-blocker or ACE or ARB-inhibition medication
* Those with hypertrophic, constrictive, or restrictive cardiomyopathies
* Those unable to lie flat in the PET scanner
* Severe major organ system dysfunction (other than heart failure)
* Significant coronary artery disease by catheterization
* Those unable to give informed consent

Primary outcomes:
measure: Average Myocardial Blood Flow
timeFrame: Study Day 2
Secondary outcomes:
measure: Average Myocardial Fatty Acid Utilization
timeFrame: Study Day 2
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Linda Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Essop MF, Opie LH. Metabolic therapy for heart failure. Eur Heart J. 2004 Oct;25(20):1765-8. doi: 10.1016/j.ehj.2004.08.019. No abstract available.
citation: Taegtmeyer H, Salazar R. Myocardial metabolism: a new target for the treatment of heart disease? Curr Hypertens Rep. 2004 Dec;6(6):414-5. doi: 10.1007/s11906-004-0033-5. No abstract available.
citation: Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. doi: 10.1152/physrev.00006.2004.
citation: Kenchaiah S, Evans JC, Levy D, Wilson PW, Benjamin EJ, Larson MG, Kannel WB, Vasan RS. Obesity and the risk of heart failure. N Engl J Med. 2002 Aug 1;347(5):305-13. doi: 10.1056/NEJMoa020245.
citation: Peterson LR, Herrero P, Schechtman KB, Racette SB, Waggoner AD, Kisrieva-Ware Z, Dence C, Klein S, Marsala J, Meyer T, Gropler RJ. Effect of obesity and insulin resistance on myocardial substrate metabolism and efficiency in young women. Circulation. 2004 May 11;109(18):2191-6. doi: 10.1161/01.CIR.0000127959.28627.F8. Epub 2004 May 3.
citation: Kates AM, Herrero P, Dence C, Soto P, Srinivasan M, Delano DG, Ehsani A, Gropler RJ. Impact of aging on substrate metabolism by the human heart. J Am Coll Cardiol. 2003 Jan 15;41(2):293-9. doi: 10.1016/s0735-1097(02)02714-6.
citation: Peterson LR, Soto PF, Herrero P, Schechtman KB, Dence C, Gropler RJ. Sex differences in myocardial oxygen and glucose metabolism. J Nucl Cardiol. 2007 Jul;14(4):573-81. doi: 10.1016/j.nuclcard.2007.03.001. Epub 2007 Jun 27.
citation: Davila-Roman VG, Vedala G, Herrero P, de las Fuentes L, Rogers JG, Kelly DP, Gropler RJ. Altered myocardial fatty acid and glucose metabolism in idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2002 Jul 17;40(2):271-7. doi: 10.1016/s0735-1097(02)01967-8.