Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000753055
Ethics application status
Not yet submitted
Date submitted
10/08/2010
Date registered
10/09/2010
Date last updated
10/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised cross-over study of effects of vasodilator treatment on left ventricular mass and volume
in patients with chronic aortic regurgitation
Scientific title
A randomised cross-over study of effects of vasodilator treatment on left ventricular mass and volume
in patients with chronic aortic regurgitation
Secondary ID [1] 252417 0
National Heart Foundation of NewZealand grant number 1324
Universal Trial Number (UTN)
Trial acronym
No acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
aortic regurgitation 257928 0
Condition category
Condition code
Cardiovascular 258098 258098 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open label oral vasodilator treatment with dose adjusted according to blood pressure and patient tolerance. Perendopril (2 to 8mg daily) candesartan (4 to 32 mg daily)and/or amlodipine (2.5 to 10mg daily). Either one or a combination of these treatments will be administered to achieve a reduction in blood pressure and adjusted according to tolerance and blood pressure, and continued for one year
Intervention code [1] 256983 0
Treatment: Drugs
Comparator / control treatment
Usual care with treatment of blood pressure as clinically indicated. There is no washout between treatmetnts.
Control group
Active

Outcomes
Primary outcome [1] 258959 0
Difference in left ventricular end systolic volume after one year treatment on vasodilators compared to one year on usual care assessed by cardiac magnetic resonance imaging
Timepoint [1] 258959 0
Assessments performed at baseline, and after one year on each treament arm in a randomised cross over design
Secondary outcome [1] 265133 0
Difference in left ventricular mass after one year treatment on vasodilators compared to one year on usual care assessed by cardiac magnetic resonance imaging
Timepoint [1] 265133 0
Assessments performed at baseline, and after one year on each treatment arm in a randomised cross over design
Secondary outcome [2] 265296 0
Difference in left ventricular ejection fraction after one year treatment on vasodilators compared to one year on usual care assessed by cardiac magnetic resonance imaging
Timepoint [2] 265296 0
Assessments performed at baseline, and after one year on each treatment arm in a randomised cross over design
Secondary outcome [3] 265297 0
Difference in aortic root dimension after one year treatment on vasodilators compared to one year on usual care assessed by cardiac magnetic resonance imaging
Timepoint [3] 265297 0
Assessments performed at baseline, and after one year on each treatment arm in a randomised cross over design

Eligibility
Key inclusion criteria
Moderate or severe asymptomatic aortic regurgitation
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current indication for aortic valve replacement
other clinically significant cardiac disease
contraindication to cardiac magnetic resonance imaging
atrial fibrillation

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)
Randomisation would follow the baseline assessment, by telephone contact to the independent study statistician. subjects would be allocated to vasodilator treatment for one year followed by usual care for one year or vice verse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation table generated by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Blinded evaluation of end points
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 2811 0
New Zealand
State/province [1] 2811 0

Funding & Sponsors
Funding source category [1] 257435 0
Charities/Societies/Foundations
Name [1] 257435 0
National Heart Foundation of new Zealand
Country [1] 257435 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
National Heart Foundation of NZ
Address
9 Kalmia St, Greenlane, Auckland, 1030
Country
New Zealand
Secondary sponsor category [1] 256664 0
None
Name [1] 256664 0
Address [1] 256664 0
Country [1] 256664 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259456 0
National ethics Committee
Ethics committee address [1] 259456 0
Ethics committee country [1] 259456 0
New Zealand
Date submitted for ethics approval [1] 259456 0
10/08/2010
Approval date [1] 259456 0
Ethics approval number [1] 259456 0

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

Contacts
Principal investigator
Name 31502 0
Address 31502 0
Country 31502 0
Phone 31502 0
Fax 31502 0
Email 31502 0
Contact person for public queries
Name 14749 0
Ralph Stewart
Address 14749 0
Auckland City Hospital,
Park Rd,
Auckland, 1030
Country 14749 0
New Zealand
Phone 14749 0
64 9 6309943
Fax 14749 0
Email 14749 0
[email protected]
Contact person for scientific queries
Name 5677 0
Ralph Stewart
Address 5677 0
Auckland City Hospital,
Park Rd,
Auckland, 1030
Country 5677 0
New Zealand
Phone 5677 0
64 9 6309943
Fax 5677 0
Email 5677 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
No additional documents have been identified.