Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000125527
Ethics application status
Approved
Date submitted
27/03/2006
Date registered
6/04/2006
Date last updated
6/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
New Zealand Eplerenone Aortic Stenosis Trial
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
ZEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 1090 0
Condition category
Condition code
Cardiovascular 1171 1171 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eplerenone 25 to 100mg orally daily to onset of symptoms, 3 years or study end.
Intervention code [1] 955 0
Treatment: Drugs
Comparator / control treatment
Placebo orally daily to onset of symptoms, 3 years or study end.
Control group
Placebo

Outcomes
Primary outcome [1] 1575 0
Change in left ventricular mass and volumes measured by magnetic resonance imaging
Timepoint [1] 1575 0
At baseline and after onset of symptoms, at 3 years or at study end.
Secondary outcome [1] 2855 0
Change in aortic valve area and peak gradient by echocardiography, and left ventricular hypertrophy by electrocardiogram .
Timepoint [1] 2855 0
Measured at baseline, every 12 months, and after onset of symptoms or at study end.
Secondary outcome [2] 2856 0
Plasma levels of B-type natriuretic peptide and C-reactive protein.
Timepoint [2] 2856 0
Measured at baseline and every 3 months.
Secondary outcome [3] 2857 0
Symptomatic deterioration due to aortic stenosis.
Timepoint [3] 2857 0
Before study end.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone/internet
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation with stratifed allocation by site. Block size(s) have not been disclosed.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 293 0
New Zealand
State/province [1] 293 0

Funding & Sponsors
Funding source category [1] 1279 0
Charities/Societies/Foundations
Name [1] 1279 0
National Heart Foundation of NZ
Country [1] 1279 0
New Zealand
Funding source category [2] 1280 0
Commercial sector/Industry
Name [2] 1280 0
Pfizer
Country [2] 1280 0
Primary sponsor type
Commercial sector/Industry
Name
Pfizer (Investigator initated trial conducted independently of sponsor)
Address
Country
United States of America
Secondary sponsor category [1] 1133 0
Charities/Societies/Foundations
Name [1] 1133 0
National Heart Foundation of New Zealand
Address [1] 1133 0
Country [1] 1133 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2610 0
Multi-regional Ethics Committee-Auckland City Hospital
Ethics committee address [1] 2610 0
Ethics committee country [1] 2610 0
New Zealand
Date submitted for ethics approval [1] 2610 0
Approval date [1] 2610 0
Ethics approval number [1] 2610 0
AKL/2001/174
Ethics committee name [2] 2611 0
Multi-regional Ethics Committee-Whangarei Hospital
Ethics committee address [2] 2611 0
Ethics committee country [2] 2611 0
New Zealand
Date submitted for ethics approval [2] 2611 0
Approval date [2] 2611 0
Ethics approval number [2] 2611 0
AKL/2001/174
Ethics committee name [3] 2612 0
Multi-regional Ethics Committee-Hamilton Hospital
Ethics committee address [3] 2612 0
Ethics committee country [3] 2612 0
New Zealand
Date submitted for ethics approval [3] 2612 0
Approval date [3] 2612 0
Ethics approval number [3] 2612 0
AKL/2001/174
Ethics committee name [4] 2613 0
Multi-regional Ethics Committee-North Shore Hospital
Ethics committee address [4] 2613 0
Ethics committee country [4] 2613 0
New Zealand
Date submitted for ethics approval [4] 2613 0
Approval date [4] 2613 0
Ethics approval number [4] 2613 0
AKL/2001/174
Ethics committee name [5] 2614 0
Multi-regional Ethics Committee-Tauranga Hospital
Ethics committee address [5] 2614 0
Ethics committee country [5] 2614 0
New Zealand
Date submitted for ethics approval [5] 2614 0
Approval date [5] 2614 0
Ethics approval number [5] 2614 0
AKL/2001/174
Ethics committee name [6] 2615 0
Multi-regional Ethics Committee-Hawkes Bay District Health Board
Ethics committee address [6] 2615 0
Ethics committee country [6] 2615 0
New Zealand
Date submitted for ethics approval [6] 2615 0
Approval date [6] 2615 0
Ethics approval number [6] 2615 0
AKL/2001/174
Ethics committee name [7] 2616 0
Multi-regional Ethics Committee-Christchurch Hospital
Ethics committee address [7] 2616 0
Ethics committee country [7] 2616 0
New Zealand
Date submitted for ethics approval [7] 2616 0
Approval date [7] 2616 0
Ethics approval number [7] 2616 0
AKL/2001/174

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35133 0
Address 35133 0
Country 35133 0
Phone 35133 0
Fax 35133 0
Email 35133 0
Contact person for public queries
Name 10144 0
Ralph A H Stewart
Address 10144 0
Green Lane Cardiovascular Service
Cardiology Department
Auckland City Hospital
Private Bag 92 189
Auckland 1030
Country 10144 0
New Zealand
Phone 10144 0
+64 9 6309943 ext. 23668
Fax 10144 0
+64 9 6310711
Email 10144 0
rstewart@adhb.govt.nz
Contact person for scientific queries
Name 1072 0
Ralph A H Stewart
Address 1072 0
Green Lane Cardiovascular Service
Cardiology Department
Auckland City Hospital
Private Bag 92 189
Auckland 1030
Country 1072 0
New Zealand
Phone 1072 0
+64 9 6309943 ext. 23668
Fax 1072 0
+64 9 6310711
Email 1072 0
rstewart@adhb.govt.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.