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

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ClinicalTrials.gov Identifier: NCT00980031
Recruitment Status : Terminated (Funding ended prior to study completion)
First Posted : September 18, 2009
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myocardial Remodeling Drug: Eplerenone Drug: Lactose Tablet Not Applicable

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  (Clinical Trial)
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 : April 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Inspra



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 6 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980031


Locations
United States, Nebraska
Creighton University Medical Center (including ambulatory centers)
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: M Jeff Holmberg, MD, PhD Creighton Cardiology

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00980031     History of Changes
Other Study ID Numbers: 07-14634
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Creighton University:
Aldosterone Blockade
Aldosterone Receptor Blockers
cardiac chamber size
wall thickness
left ventricular ejection fraction
left atrial volumes
diastolic function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents