Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men with heart failure | Men with obesity-related heart failure |
| |
| Women with heart failure | Women with obesity-related heart failure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET (Positron Emission Tomography) | Procedure | This is a diagnostic scan that requires the injection of radioactive tracer compounds intravenously using an IV placed in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Day 2 |
Not provided
Inclusion criteria
Exclusion criteria
Males and females assigned so at birth are eligible to participate. Since the purpose was to evaluate sex-related differences in blood flow and metabolism without the effects of exogenous hormones, those taking the latter were excluded.
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Linda Peterson, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15474689 | Background | 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. | |
| 15527683 | Background | 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. |
Not provided
Not provided
Participants with nonischemic heart failure
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Men With Heart Failure | Men with obesity-related heart failure |
| FG001 | Women With Heart Failure | Women with obesity-related heart failure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants with nonischemic heart failure
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Men With Heart Failure | Men with obesity-related heart failure |
| BG001 | Women With Heart Failure | Women with obesity-related heart failure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants who completed the PET scan assessment | Posted | Mean | Standard Deviation | mL/g/minute | Study Day 2 |
|
All-cause mortality and treatment-emergent adverse events were collected from Study Day 1 to 48 hours after Study Day 2.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Men With Heart Failure | Men with obesity-related heart failure | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda R. Peterson, MD, Professor of Medicine and Radiology | Washington University School of Medicine | 314-362-4577 | lpeterso@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D059552 | Caves |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D055593 | Geological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Non diagnostic genetic samples
|
| Echocardiogram | Procedure | An echocardiogram is an ultrasound of the heart. Participants received a complete 2D- and Doppler echocardiographic examination on the day of the PET scan. |
|
|
| ^15O-water | Radiation | 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. |
|
| 1-^11C-palmitate | Radiation | 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. |
|
| 1-^11C-glucose | Radiation | 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.. |
|
| 15987803 | Background | 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. |
| 12151467 | Background | 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. |
| 15123530 | Background | 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. |
| 12535825 | Background | 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. |
| 17679067 | Background | 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. |
| 12106931 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Homeostasis model assessment of insulin resistance | HOMA-IR is a method to estimate insulin resistance. It is calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. A score of <1 indicates insulin-sensitivity; >1.9 indicates early insulin resistance; and >2.9 indicates significant insulin resistance. | Mean | Standard Deviation | units on a scale |
|
| Body Mass Index (BMI) | Body mass index (BMI) is a measure of body fat based on height and weight. It is calculated as body weight divided by the square of body height. Underweight = <18.5; normal weight = 18.5 to 24.9; overweight = 25 to 29.9; and obesity is >30. | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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. | Participants who completed the PET assessment | Posted | Mean | Standard Deviation | nmol/g/minute | Study Day 2 |
|
|
|
|
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Women With Heart Failure | Women with obesity-related heart failure | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D055585 | Physical Phenomena |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |