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Trial record 32 of 221 for:    Aldosterone

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980031
Recruitment Status : Terminated (Funding ended prior to study completion)
First Posted : September 18, 2009
Last Update Posted : March 28, 2014
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.

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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

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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00980031

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

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Responsible Party: Creighton University 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:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents