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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00980031

Acronym

Aldosterone

Enrollment

Registered

2009-09-18

Start date

2007-04-30

Completion date

2011-09-30

Last updated

2014-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Remodeling

Keywords

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

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.

Interventions

DRUGEplerenone

25mg PO daily (QD)for 6 months

DRUGLactose Tablet

Lactose tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Blood Pressure	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026