None listed
Conditions
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.
Interventions
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.
Sponsors
Safehouse Innovation Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed