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| ID | Type | Description | Link |
|---|---|---|---|
| 060369 |
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Lack of enrollment
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The combination of high blood pressure and having central obesity is an increasing important factor for heart disease in men and women. It can also lead to the early development of hardening of the arteries and increased risk of a stroke. This study will analyze patients' genetic make up to identify who may be at greater risk for heart disease and strokes in relationship to high blood pressure and central obesity.
Obesity is an increasingly important risk factor for cardiovascular disease in men and women and is associated with the premature development of atherosclerosis, and increased risk of stroke. A classical perspective of cardiovascular risk does not adequately explain all of the cardiovascular events associated with obesity. Elevated plasma levels of plasminogen activator inhibitor type I (PAI-1) are one of the biochemical hallmarks for obesity and likely contribute the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that the increased risk of atherothrombotic events in patients with obesity. The central hypothesis of this proposal is that vascular PAI-1 excess promotes the development of intravascular thrombosis. We will test the hypothesis that secreted factors from adipocytes have autocrine, paracrine and endocrine effects that have a deleterious effect on the fibrinolytic system, either by enhancing PAI-1 production or impairing endothelial t-PA release. From a public health perspective, there is no greater threat to America's cardiovascular health than the epidemic of obesity. It is anticipated that this study will provide new insights nto the molecular mechanisms that contribute to the development of fibrinolytic dysfunction and cardiovascular disease in obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Active Comparator | Eplerenone (study drug) |
|
| Treatment B | Active Comparator | Ramipril |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | 5 mg x 1 week followed by 10 mg x 9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release | 10-Week period | |
| This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity. | 10-weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subjects who smoke
Women who are pregnant (confirmed by urine beta-HCG).
Women who are breast feeding
Subjects with documentation of the following health risk:
Subjects who are currently taking the following medications:
Warfarin
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| Name | Affiliation | Role |
|---|---|---|
| James AS Muldowney, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | The study was never unblinded as enrollment was never completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | The study was never unblinded as enrollment was never completed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Secreted Factors From Adipocytes Have Autocrine, Paracrine and Endocrine Effects That Have a Deleterious Effect on the Fibrinolytic System, Either by Enhancing PAI-1 Production or Impairing Endothelial t-PA Release | Enrollment was never completed so study was never unblinded and data was never analyzed | Posted | 10-Week period |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | The study was never unblinded as enrollment was never completed. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Muldowney | Vanderbilt University Medical Center | 615-936-1720 | james.muldowney@vanderbilt.edu |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| D017257 | Ramipril |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Ramipril | Drug | Ramipril 5mg qd x 1 week f/b Ramipril qd x 9 weeks. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary | This Study Will Analyze Patients' Genetic Make up to Identify Who May be at Greater Risk for Heart Disease and Strokes in Relationship to High Blood Pressure and Central Obesity. | Enrollment was never completed so study was never unblinded and data was never analyzed | Posted | 10-weeks |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |