Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension

Conditions
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Myocardial Remodeling

Intervention / Treatment
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* Drug: Eplerenone
* Drug: Lactose Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treated and controlled hypertension Less than 140/90 in non-diabetics Less than 130/80 in diabetics Exclusion Criteria: currently receiving an aldosterone blocker clinical evidence of congestive heart failure prior myocardial infarction renal dysfunction with a creatinine clearance of less than 40ml/min serum potassium > 5.5meq/L at initiation concomitant use of a medication that inhibits the CYP3A4 enzyme (ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lactose Tablet<br>Compounded capsule using Lactose Monohydrate Powder | Drug: Lactose Tablet<br>* Lactose tablet<br>|
| Active Comparator: Eplerenone<br>25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder. | Drug: Eplerenone<br>* 25mg PO daily (QD)for 6 months<br>* Other names: Inspra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aldosterone Blockade, Aldosterone Receptor Blockers, cardiac chamber size, wall thickness, left ventricular ejection fraction, left atrial volumes, diastolic function