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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2011-09-30

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.

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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.

Conditions

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Myocardial Remodeling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Lactose Tablet

Compounded capsule using Lactose Monohydrate Powder

Group Type PLACEBO_COMPARATOR

Lactose Tablet

Intervention Type DRUG

Lactose tablet

Eplerenone

25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.

Group Type ACTIVE_COMPARATOR

Eplerenone

Intervention Type DRUG

25mg PO daily (QD)for 6 months

Interventions

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Eplerenone

25mg PO daily (QD)for 6 months

Intervention Type DRUG

Lactose Tablet

Lactose tablet

Intervention Type DRUG

Other Intervention Names

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Inspra

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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No