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

Myocardial Remodeling Clinical Trial

— Aldosterone  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00980031
• Other study ID #: 07-14634
• Status: Terminated
• Phase: N/A
• First received: September 11, 2009
• Last updated: March 27, 2014
• Start date: April 2007
• Est. completion date: September 2011

Study information

• Verified date: March 2014
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension
• Myocardial Remodeling

Intervention

Drug:
• Eplerenone
25mg PO daily (QD)for 6 months
• Lactose Tablet
Lactose tablet

Locations

Country	Name	City	State
United States	Creighton University Medical Center (including ambulatory centers)	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram		6 months	No
Secondary	Blood Pressure		6 months	No