Heart Failure, Obesity
Conditions
Keywords
Obesity, Heart, Failure, PET (positron emission tomography), radiation, metabolism
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.
Interventions
PROCEDUREPET (Positron Emission Tomography)
This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm.
PROCEDUREEchocardiogram
An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan.
RADIATION^15O-water
This is a radioactive tracer used to study blood flow in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
RADIATION1-^11C-palmitate
This is a radioactive tracer used to study fatty acid usage in the heart during the PET scan. It was administered intravenously at a dose of 20 mCi.
RADIATION1-^11C-glucose
This is a radioactive tracer used to study glucose usage in the heart during the PET scan. It was administered intravenously at a dose of 20 Mci..
Sponsors
The Foundation for Barnes-Jewish Hospital
Washington University School of Medicine
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Myocardial Blood Flow | Study Day 2 | Myocardial blood flow (MBF) was measured using \^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Myocardial Fatty Acid Utilization | Study Day 2 | Myocardial fatty acid (FA) utilization was measured using 1-\^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2. |
Countries
United States
Participant flow
Pre-assignment details
Participants with nonischemic heart failure
Participants by arm
| Arm | Count |
|---|---|
| Men With Heart Failure Men with obesity-related heart failure | 9 |
| Women With Heart Failure Women with obesity-related heart failure | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | Men With Heart Failure | Total | Women With Heart Failure |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 3 | 41.5 years STANDARD_DEVIATION 9.2 | 41 years STANDARD_DEVIATION 3 |
| Body Mass Index (BMI) | 31 kg/m^2 STANDARD_DEVIATION 2 | 32.96 kg/m^2 STANDARD_DEVIATION 7.54 | 35 kg/m^2 STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Homeostasis model assessment of insulin resistance | 2.55 units on a scale STANDARD_DEVIATION 0.51 | 3.52 units on a scale STANDARD_DEVIATION 4.19 | 4.40 units on a scale STANDARD_DEVIATION 1.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 14 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Average Myocardial Blood Flow
Myocardial blood flow (MBF) was measured using \^15O-water injected intravenously intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Time frame: Study Day 2
Population: Participants who completed the PET scan assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Men With Heart Failure | Average Myocardial Blood Flow | 0.73 mL/g/minute | Standard Deviation 0.17 |
| Women With Heart Failure | Average Myocardial Blood Flow | 0.97 mL/g/minute | Standard Deviation 0.13 |
Comparison: Average myocardial blood flow, men versus womenp-value: <0.005Student's t-test
Secondary
Average Myocardial Fatty Acid Utilization
Myocardial fatty acid (FA) utilization was measured using 1-\^11C-palmitate injected intravenously through a large bore catheter into an antecubital vein during the (Positron Emission Tomography (PET) scan on Study Day 2.
Time frame: Study Day 2
Population: Participants who completed the PET assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Men With Heart Failure | Average Myocardial Fatty Acid Utilization | 85 nmol/g/minute | Standard Deviation 26 |
| Women With Heart Failure | Average Myocardial Fatty Acid Utilization | 139 nmol/g/minute | Standard Deviation 68 |
Comparison: Average myocardial fatty acid utilization, men versus womenp-value: <0.05Student's t-test