New Zealand Eplerenone Aortic Stenosis Trial

A randomised double blind placebo controlled trial to investigate the effects of long term treatment with the aldosterone receptor antagonist eplerenone on left ventricular mass and volume with magnetic resonance imaging in asymptomatic aortic stenosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000125527

Acronym

ZEST

Enrollment

Registered

2006-04-06

Start date

2003-06-06

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Aortic stenosis desribes a narrowing of the valve which opens to allow blood to be pumped from the heart. This narrowing increases the work of the heart and because of this heart function often deteriorates. The aim of this study is to determine whether eplerenone, an aldosterone receptor antagonist which has already been shown to benefit patients with heart failure, can prevent worsening of heart function in patients with moderate or severe aortic stenosis.

Interventions

Eplerenone 25 to 100mg orally daily to onset of symptoms, 3 years or study end.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Aortic stenosis with peak velocity across valve by doppler of >3.0m/s, normal left ventricular function by echocardiography, asymptomatic for aortic stenosis.

Exclusion criteria

Known sensitivity to study medication or spironolactone, age < 18 years, previous aortic valve replacement or scheduled aortic valve replacement with 3 months, other significant heart valve disease of > moderate severity, acute coronary syndrome within previous 6 months, signficant co-morbidity, use of potassium sparing diuretics, serum creatinine >0.13mmol/l during screening period, serum potassium >5.0mmol/l during the screening period, likely poor compliance, gastrointestinal disease which may interefer with the absorption, pharmacokinetics or elimination of eplerenone, left ventricular outlfow obstrcution from a cause other than aortic stenosis, contrindication to magnetic resonance imaging, current enrolment in an investigational drug or device trial, pregant or lactating women or potential for conception, or any condition which in the patient's doctors opinion makes participation in the trial not in the best interest of the patient.

Outcome results