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

March 27, 2014 updated by: Creighton University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Medical Center (including ambulatory centers)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood Pressure
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creighton University

Investigators

  • Principal Investigator: M Jeff Holmberg, MD, PhD, Creighton Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 17, 2009

First Posted (ESTIMATE)

September 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 27, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-14634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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