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

Creighton University

Status

Terminated

Conditions

Myocardial Remodeling

Treatments

Drug: Lactose Tablet

Drug: Eplerenone

Study type

Interventional

Funder types

Other

Identifiers

NCT00980031

07-14634

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

19+ years old

Volunteers

No 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)