Back to results

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

Primary Purpose

Myocardial Remodeling

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Eplerenone

Lactose Tablet

About this trial

This is an interventional prevention trial for Myocardial Remodeling focused on measuring Aldosterone Blockade, Aldosterone Receptor Blockers, cardiac chamber size, wall thickness, left ventricular ejection fraction, left atrial volumes, diastolic function

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Creighton University Medical Center (including ambulatory centers)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Lactose Tablet

Eplerenone

Arm Description

Compounded capsule using Lactose Monohydrate Powder

25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.

Outcomes

Primary Outcome Measures

Myocardial Remodeling (cardiac chamber sizes, wall thickness, left ventricular ejection fraction, left atrial volumes, and diastolic function) assessed by transthoracic echocardiogram

Secondary Outcome Measures

Blood Pressure

Full Information

NCT ID

NCT00980031

First Posted

September 11, 2009

Last Updated

March 27, 2014

Sponsor

Creighton University

1. Study Identification

Unique Protocol Identification Number

NCT00980031

Brief Title

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

Acronym

Aldosterone

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Funding ended prior to study completion

Study Start Date

April 2007 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creighton University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Remodeling

Keywords

Aldosterone Blockade, Aldosterone Receptor Blockers, cardiac chamber size, wall thickness, left ventricular ejection fraction, left atrial volumes, diastolic function

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lactose Tablet

Arm Type

Placebo Comparator

Arm Description

Compounded capsule using Lactose Monohydrate Powder

Arm Title

Eplerenone

Arm Type

Active Comparator

Arm Description

25 mg tablet placed in a capsule filled with Lactose Monohydrate Powder.

Intervention Type

Drug

Intervention Name(s)

Eplerenone

Other Intervention Name(s)

Inspra

Intervention Description

25mg PO daily (QD)for 6 months

Intervention Type

Drug

Intervention Name(s)

Lactose Tablet

Intervention Description

Lactose tablet

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Blood Pressure

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M Jeff Holmberg, MD, PhD

Organizational Affiliation

Creighton Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center (including ambulatory centers)

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs