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

Not Applicable

Terminated

• Conditions: Myocardial Remodeling
• Interventions: Drug: Eplerenone; Drug: Lactose Tablet

• Registration Number: NCT00980031
• Lead Sponsor: Creighton University

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.

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 Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-27
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eplerenone	Eplerenone	25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.
Lactose Tablet	Lactose Tablet	Compounded capsule using Lactose Monohydrate Powder

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blood Pressure	6 months

Trial Locations

Locations (1)

Creighton University Medical Center (including ambulatory centers); 🇺🇸 Omaha, Nebraska, United States