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

This study has been terminated.
(Funding ended prior to study completion)
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00980031
First received: September 11, 2009
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Myocardial Remodeling
 Drug: Eplerenone
Drug: Lactose Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Aldosterone Blockade to Prevent Myocardial Remodeling In Patients With Controlled Essential Hypertension

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 QD for 6 months
Other Name: Inspra

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00980031     History of Changes
Other Study ID Numbers: 07-14634
Study First Received: September 11, 2009
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

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
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013