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Sex and Obesity: Effects on Heart Failure Study

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The Washington University

Status

Completed

Conditions

Obesity
Heart Failure

Treatments

Procedure: PET (Positron Emission Tomography)
Radiation: 1-^11C-palmitate
Procedure: Echocardiogram
Radiation: ^15O-water
Radiation: 1-^11C-glucose

Study type

Observational

Funder types

Other

Identifiers

NCT00776035
07-1128

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

19 participants in 2 patient groups

Men with heart failure
Description:
Men with obesity-related heart failure
Treatment:
Radiation: 1-^11C-glucose
Procedure: Echocardiogram
Radiation: ^15O-water
Radiation: 1-^11C-palmitate
Procedure: PET (Positron Emission Tomography)
Women with heart failure
Description:
Women with obesity-related heart failure
Treatment:
Radiation: 1-^11C-glucose
Procedure: Echocardiogram
Radiation: ^15O-water
Radiation: 1-^11C-palmitate
Procedure: PET (Positron Emission Tomography)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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