Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000835246
Ethics application status
Approved
Date submitted
24/09/2009
Date registered
25/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of spironolactone versus placebo in patients with a hypertensive response to exercise
Scientific title
The effect of spironolactone versus placebo on fibrosis in patients with a hypertensive response to exercise
Universal Trial Number (UTN)
Trial acronym
HRE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-hypertension 251917 0
Condition category
Condition code
Cardiovascular 252094 252094 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Spironolactone oral, 25 mg/d, 3 months
2) Exercise - 30 minute sessions of aerobic and resistance training, 5 days per week for 3 months, iincluding 2 supervised small group sessions with an exercise physiologist.
3) Participants receive these interventions sequentially (ie there are 2 separate treatment arms)
4) The washout interval will be at least 3 months
Intervention code [1] 241336 0
Treatment: Drugs
Intervention code [2] 241344 0
Treatment: Other
Comparator / control treatment
Placebo oral, 5 mg sugar pill once daily, 3 months
Control group
Placebo

Outcomes
Primary outcome [1] 252975 0
Reduction of fibrosis, as assessed by backscatter and strain markers
Timepoint [1] 252975 0
Baseline vs 3 months following randomisation
Secondary outcome [1] 257732 0
Improvement in diastolic function using tissue Doppler echocardiography, measured as tissue diastolic velocity (e')
Timepoint [1] 257732 0
Baseline and 3 months following randomisation

Eligibility
Key inclusion criteria
Hypertensive response to exercise (HRE); maximum SBP/DBP (systolic/diastolic blood pressure) response to exercise >210/105 mmHg in men and >190/105 mmHg for women
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) hypertension at rest (>140/90 mmHg or on treatment for hypertension), 2) known coronary artery disease (angina, previous infarction, previous positive diagnostic test), 3) diabetes mellitus

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer entry of recruitment data produces a coded prescription which is filled by a pharmacist independent of the trial. Identity of patients on each treatment is kept at pharmacy and released when the databse is locked
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243786 0
Charities/Societies/Foundations
Name [1] 243786 0
National Heart Foundation
Country [1] 243786 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Research Training Division
The University of Queensland
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 237142 0
None
Name [1] 237142 0
Address [1] 237142 0
Country [1] 237142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243916 0
Princess Alexandra Hospital Research Ethics Committee
Ethics committee address [1] 243916 0
Princess Alexandra Hospital
Ipswich Road
Brisbane
Qld 4102
Ethics committee country [1] 243916 0
Australia
Date submitted for ethics approval [1] 243916 0
Approval date [1] 243916 0
21/08/2006
Ethics approval number [1] 243916 0
2001/113

Summary
Brief summary
The aims of this study are to show that patients with hypertension and abnormal left ventricular (LV) filling (but without coronary artery disease) may have their echocardiographic and biochemical markers of myocardial fibrosis and diastolic function improved by treatment with spironolactone, an aldosterone antagonist with anti-fibrotic properties.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30326 0
Address 30326 0
Country 30326 0
Phone 30326 0
Fax 30326 0
Email 30326 0
Contact person for public queries
Name 13573 0
Dr T Marwick
Address 13573 0
University of Queensland Dept of Medicine
Princess Alexandra Hospital
Brisbane, Qld 4102
Country 13573 0
Australia
Phone 13573 0
+61-7-3240-5345
Fax 13573 0
+61-7-3240-5399
Email 13573 0
[email protected]
Contact person for scientific queries
Name 4501 0
Dr T Marwick
Address 4501 0
University of Queensland Dept of Medicine
Princess Alexandra Hospital
Brisbane, Qld 4102
Country 4501 0
Australia
Phone 4501 0
+61-7-3240-5345
Fax 4501 0
+61-7-3240-5399
Email 4501 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseImprovement in functional capacity with spironolactone masks the treatment effect on exercise blood pressure.2022https://dx.doi.org/10.1016/j.jsams.2021.09.008
N.B. These documents automatically identified may not have been verified by the study sponsor.