N/A
N=19
Sex and Obesity: Effects on Heart Failure Study
Obesity · Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00776035 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Average Myocardial Blood Flow — 0.73; 0.97 mL/g/minute — p=<0.005
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PET (Positron Emission Tomography) (Procedure); Echocardiogram (Procedure); ^15O-water (Radiation); 1-^11C-palmitate (Radiation); 1-^11C-glucose (Radiation)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Myocardial Blood Flow |
0.73; 0.97 | <0.005 sig |
| SECONDARY Average Myocardial Fatty Acid Utilization |
85; 139 | <0.05 sig |
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 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
Data sourced from ClinicalTrials.gov (NCT00776035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.