Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000933459
Ethics application status
Approved
Date submitted
8/07/2016
Date registered
13/07/2016
Date last updated
6/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the use of spironolactone on the endothelial glycocalyx in high blood pressure
Scientific title
Assessment of spironolactone on the endothelial glycocalyx in hypertension
Secondary ID [1] 289636 0
ASGARD E35-2015
Universal Trial Number (UTN)
U1111-1185-1956
Trial acronym
ASGARD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 299427 0
Condition category
Condition code
Cardiovascular 299407 299407 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spironolactone 25mg, oral tablet, once daily. Adherence to be monitored by questionnaire and return of empty drug packets.
Intervention code [1] 295249 0
Treatment: Drugs
Comparator / control treatment
Compared to patients receiving indapamide 2.5mg, oral tablet, daily. Adherence to be monitored by questionnaire and return of empty drug packets.
Control group
Active

Outcomes
Primary outcome [1] 298876 0
Change in glycocalyx parameters by:
1. Glycocheck value (sublingual camera measurement of the glycocalyx)
2. ELISA of syndecan-1 on serum samples
3. ELISA of hyaluronan on serum samples
Timepoint [1] 298876 0
3 months post commencement of study drug
Secondary outcome [1] 325514 0
Change in markers of endothelial dysfunction by:
1. ELISA of von Willebrand Factor on serum samples
2. ELISA of vascular cell adhesion molecule-1 (VCAM-1) on serum samples
3. Urinary microalbuminuria
Timepoint [1] 325514 0
3 months post commencement of study drug

Eligibility
Key inclusion criteria
Hypertension on 24-hr ambulatory blood pressure monitoring (>140/90mmHg)
and/or hypertensive event e.g. stroke
Microalbuminuria (spot urine ACR > 3 mg/mmol)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy, pregnancy, inability to consent, known haematological disorders, eGFR <60

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previously published article (Nieuwdorp et al, J Appl Physiol 2008), the number required to detect a 0.2micrometre difference in the glycocalyx for a significance level of 5% and power of 80% in a paired design (i.e. measuring outcomes before and after an intervention) is n=10. To factor in drop-outs, we plan to recruit n=15 in each arm (total 30).

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/07/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6131 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 6132 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 6133 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 13574 0
3128 - Box Hill
Recruitment postcode(s) [2] 13575 0
3135 - Ringwood East
Recruitment postcode(s) [3] 13576 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 294016 0
University
Name [1] 294016 0
Eastern Clinical Research Unit, Monash Univeresity
Country [1] 294016 0
Australia
Primary sponsor type
Hospital
Name
Department of Renal Medicine, Box Hill Hospital
Address
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country
Australia
Secondary sponsor category [1] 292836 0
None
Name [1] 292836 0
Address [1] 292836 0
Country [1] 292836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295428 0
Eastern Health HREC
Ethics committee address [1] 295428 0
Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Ethics committee country [1] 295428 0
Australia
Date submitted for ethics approval [1] 295428 0
19/05/2016
Approval date [1] 295428 0
07/07/2016
Ethics approval number [1] 295428 0

Summary
Brief summary
The glycocalyx is a particle that is important in maintaining blood vessel health. High blood pressure is common, closely related to salt regulation, and affects the health of blood vessels. Animal studies have shown that the glycocalyx is affected in high blood pressure. Laboratory studies indicate that the use of spironolactone, a common blood pressure medication, can offset the effects of a high-salt environment on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have high blood pressure, whether the glycocalyx can be improved with good blood pressure control, and whether spironolactone has any additional protective benefits on the glycocalyx.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67274 0
Dr Hui Liew
Address 67274 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67274 0
Australia
Phone 67274 0
+61390918870
Fax 67274 0
Email 67274 0
[email protected]
Contact person for public queries
Name 67275 0
Dr Hui Liew
Address 67275 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67275 0
Australia
Phone 67275 0
+61390918870
Fax 67275 0
Email 67275 0
[email protected]
Contact person for scientific queries
Name 67276 0
Dr Hui Liew
Address 67276 0
Department of Renal Medicine, Box Hill Hospital, Level 2, 5 Arnold Street, Box Hill 3128, Victoria
Country 67276 0
Australia
Phone 67276 0
+61390918870
Fax 67276 0
Email 67276 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.