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Trial registered on ANZCTR


Registration number
ACTRN12619000960156p
Ethics application status
Submitted, not yet approved
Date submitted
21/06/2019
Date registered
8/07/2019
Date last updated
8/07/2019
Date data sharing statement initially provided
8/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a New Novel Fluid Monitoring Device in Heart Failure Patients
Scientific title
Assessment of a New Novel Fluid Monitoring Device in Heart Failure Patients
Secondary ID [1] 298571 0
CT-2019-CTN-01580-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive heart failure (CHF) 313410 0
Condition category
Condition code
Cardiovascular 311844 311844 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who provide consent to take part in the study will be asked to wear an adhesive leg band strip with 5 bio-impedance sensors attached horizontally around the back of their calf. This leg band will remain attached for up to 8 hours at a time and data will be collected over a 3 day period. The leg band will be connected to a data recording unit which can be disconnected when required.
Intervention code [1] 314831 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320516 0
The primary objective of the study is to record changes in bio-impedance over a three day period in hospitalised heart failure patients.
Timepoint [1] 320516 0
Participants will be directly recruited for the study following admission to the heart failure clinic or from the cardiac ward. Patients will be recruited when showing signs of significant fluid overload associated with a heart failure condition.
Secondary outcome [1] 371884 0
N/A
Timepoint [1] 371884 0
N/A

Eligibility
Key inclusion criteria
• Male and female Age 18 years+
• Heart failure Condition
• Hospitalised with significant fluid overload for fluid offload.
• Ability to give written informed consent and agree to adhere to all protocol requirements.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patient has been prescribed to wear TED stockings throughout the duration of their hospital stay.
• Leg prosthesis or other disorders making measurement of leg oedema difficult or inadvisable.
• Pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This study will utilise 20 participants in total.

The data collected from this study will be analysed to determine whether a correlation can be seen between bio-impedance readings and changes in fluid status in heart failure patients.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 21631 0
Singapore
State/province [1] 21631 0
Singapore

Funding & Sponsors
Funding source category [1] 303109 0
Commercial sector/Industry
Name [1] 303109 0
Safehouse Innovation Ltd
Address [1] 303109 0
Level 4
543 Bridge Road (PO Box 12)
Richmond
Victoria
Australia
3121
Country [1] 303109 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Safehouse Innovation Ltd
Address
Level 4
543 Bridge Road (PO Box 12)
Richmond
Victoria
Australia
3121
Country
Australia
Secondary sponsor category [1] 303103 0
None
Name [1] 303103 0
Address [1] 303103 0
Country [1] 303103 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303659 0
Alfred Health Ethics Committee
Ethics committee address [1] 303659 0
The Alfred
55 Commercial Rd,
Melbourne
VIC
3004
Ethics committee country [1] 303659 0
Australia
Date submitted for ethics approval [1] 303659 0
06/06/2019
Approval date [1] 303659 0
Ethics approval number [1] 303659 0

Summary
Brief summary
A prototype bio-impedance recording device called Cardia [TIP2] has been developed by Melbourne based medical device company Grey Innovation. An earlier prototype of this device [TIP1] has already undergone a clinical study (CTN-03513-1) in dialysis patients where 16 patients wore the device over 19 sessions lasting 4-6 hours each. It was found that changes in bio-impedance were reliably measured with the Cardia [TIP2] prototype - correlating with fluid removed from the participant during dialysis.
This study will enable the prototype to be tested in heart failure patients, the end user population over a longer period of time. This study will provide information that will enable us to move towards an optimised device that is to be tested in a large-scale home-based trial. The home-based trial will compare those who do have the real-time volume status information to act upon against those who do not and will assess whether relevant clinical outcomes can be improved, i.e. prevention of heart failure re-hospitalisation or minimisation of time in hospital for acute decompensation. Thus, this specific project is critical in advancing the commercial and therapeutic/diagnostic potential of the device, before such a study can be considered.
Our goal is that this will ultimately lead to the development of a commercially viable, low-cost (potentially disposable), non-invasive approach to assessment of fluid status to allow early intervention and increase health outcomes in heart failure patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94414 0
Prof David Kaye
Address 94414 0
Alfred Health
55 Commercial Rd,
Melbourne
VIC
3004
Country 94414 0
Australia
Phone 94414 0
+61 390762000
Fax 94414 0
Email 94414 0
D.Kaye@alfred.org.au
Contact person for public queries
Name 94415 0
Mr Kevin Noble
Address 94415 0
Grey Innovation Pty Ltd
Level 4
543 Bridge Road (PO Box 12)
Richmond
Victoria
Australia
3121
Country 94415 0
Australia
Phone 94415 0
+61 3 8459 6999
Fax 94415 0
Email 94415 0
kevin.noble@greyinnovation.com
Contact person for scientific queries
Name 94416 0
Mr Kevin Noble
Address 94416 0
Grey Innovation Pty Ltd
Level 4
543 Bridge Road (PO Box 12)
Richmond
Victoria
Australia
3121
Country 94416 0
Australia
Phone 94416 0
+61 3 8459 6999
Fax 94416 0
Email 94416 0
kevin.noble@greyinnovation.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data to inform subsequent product development only
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2419 0
Study protocol
Citation [1] 2419 0
Link [1] 2419 0
Email [1] 2419 0
kevin.noble@greyinnovation.com
Other [1] 2419 0
Attachment [1] 2419 0
Summary results
No Results