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Funding ended prior to study completion
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The goal of this project is to investigate the effects that the addition of aldosterone blockade with eplerenone will have on the progression of diastolic dysfunction in patients with controlled essential hypertension.
The purpose of this project is to determine if eplerenone, an aldosterone blocker, prevents remodelling of the heart in patients with controlled essential hypertension, defined as having a blood pressure of equal to or less than 130/80 in diabetics and equal to or less than 140/90 in non-diabetics. This study will investigate if the addition of 25 milligrams of eplerenone daily to a subject's hypertension medication regimen will prevent the progression or development of diastolic dysfunction. Echocardiography will be used to measure the changes in heart structure of subjects receiving eplerenone versus subjects receiving placebo (a drug that may resemble the study drug but contains no active ingredient). Approximately 30 subjects will take part in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose Tablet | Placebo Comparator | Compounded capsule using Lactose Monohydrate Powder |
|
| Eplerenone | Active Comparator | 25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | 25mg PO daily (QD)for 6 months |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Jeff Holmberg, MD, PhD | Creighton Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Creighton University Medical Center (including ambulatory centers) | Omaha | Nebraska | 68131 | United States |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Lactose Tablet | Drug | Lactose tablet |
|
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |