ew Zealand Eplerenone Aortic Stenosis Trial

Phase 2

Completed

• Conditions: Aortic stenosis; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12606000125527
• Lead Sponsor: Pfizer (Investigator initated trial conducted independently of sponsor)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass and volumes measured by magnetic resonance imaging[At baseline and after onset of symptoms, at 3 years or at study end.]

Secondary Outcome Measures

Name	Time	Method
Change in aortic valve area and peak gradient by echocardiography, and left ventricular hypertrophy by electrocardiogram .[Measured at baseline, every 12 months, and after onset of symptoms or at study end.];Plasma levels of B-type natriuretic peptide and C-reactive protein.[Measured at baseline and every 3 months.];Symptomatic deterioration due to aortic stenosis.[Before study end.]