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

Sponsor

Creighton University (Other)

Overall Status

Terminated

CT.gov ID

NCT00980031

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Remodeling	Drug: Eplerenone Drug: Lactose Tablet	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Lactose Tablet Compounded capsule using Lactose Monohydrate Powder	Drug: Lactose Tablet Lactose tablet
Active Comparator: Eplerenone 25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.	Drug: Eplerenone 25mg PO daily (QD)for 6 months Other Names: Inspra

Arm

Intervention/Treatment

Placebo Comparator: Lactose Tablet

Compounded capsule using Lactose Monohydrate Powder

Drug: Lactose Tablet

Lactose tablet

Active Comparator: Eplerenone

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

Drug: Eplerenone

25mg PO daily (QD)for 6 months

Other Names:

Inspra

Outcome Measures

Primary Outcome Measures

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

Blood Pressure [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)