Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000038695
Ethics application status
Approved
Date submitted
22/12/2022
Date registered
13/01/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
13/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the accuracy of Wearables and Algorithm Technology for Chronic Heart Disease in the diagnosis of Heart Failure
Scientific title
A Proof Of Concept study to evaluate the sensitivity and specificity of Wearables and Algorithm Technology for Chronic Heart Disease in the diagnosis of Heart Failure.
Secondary ID [1] 308658 0
SAIIV-CIP-04
Universal Trial Number (UTN)
Trial acronym
POC WATCH HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 328578 0
Condition category
Condition code
Cardiovascular 325593 325593 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to compare the accuracy of propriatary hardware (morphic sensors) in collecting heamodynamic signals in patients with Heart Failure, compared to the commonly used Gold standard devices.
Participants will be recruited by the Principal Investigator (Cardiologist) at each site and will be previously indicated for a right heart catheter (RHC) as part of standard of care (SOC). Research staff will initially pre-screen participants against the eligibility criteria to assess eligibility and once confirmed the participant will be invited to participate and consented into the study.
Baseline data will be collected within 1 week of the RHC. Baseline data collection will include demographics, medical/surgical history, and concomitant medication usage, specific to heart failure medication. A blood sample will also be collected to measure N-terminal pro b-type natriuretic peptide (NT-proBNP).
The study will be broken into two parts occurring on the same day. Each participant must consent to both parts of the study to be included in the trial. The two parts will consist of 1. Non-Invasive Study and 2. Invasive (RHC) study.
The non-invasive study will be completed in a consultation room or echocardiogram lab and will take approximately 30 minutes to complete. During the non-invasive study the participant will be connected to several gold standard devices to measure signals, and these will be compared to the morphic sensors. Four morphic sensors will be attached to the participant; Sensor 1 over the cardiac apex, Sensor 2 over the suprasternal notch, Sensor 3 over the left carotid artery and Sensor 4 on the left index finger. The participant will then undergo a routine echocardiogram, and continuous monitoring with the BIOPAC which will simultaneously collect signals using ECG, PCG (Piezo), BP Pulse Wave and PPG. Signals will also be collected using a Sphygmocor.
The standard of care measurements that will be taken include:
• ECG
• Phonocardiogram sounds
• Pulse Wave Velocity (meters/second)
• Central blood pressure (mmHg)
• Peripheral blood pressure (mmHg)
• Pre-ejection period (milliseconds)
• Central pulse arrival time (milliseconds)
• Peripheral pulse arrival time (milliseconds)
• Central pulse transit time (milliseconds)
• Peripheral pulse transit time (milliseconds)
• Left ventricular filling time (milliseconds)
• Left ventricular ejection period (milliseconds)
• Left ventricular ejection fraction (%).
These standard of care measurements will be taken at the same time that the morphic sensors will be attached and collecting data. The sensors will collect data continuously for approximately 5-10 minutes. The cardiologist may provide instructions during the monitoring, such as standing up, laying down, coughing, etc. These instructions will be in line with SOC, and are not an additional requirement of the morphic sensors.

The invasive study (right heart catheter) will be complete in a catheterisation lab. The right heart catheter (Swan Ganz catheter) will be paced in the pulmonary artery. This will be completed in line with SOC, following the hospital guidelines. Prior to RHC, a qualified study team member (i.e. interventional radiologist, cardiologist, or research nurse) will attach four morphic sensors to the participant, Sensor 1 over the cardiac apex, Sensor 2 over the suprasternal notch, Sensor 3 over the left carotid artery and Sensor 4 on the left index finger. The participant will also have an ECG, PCG (Piezo), BP Pulse Wave and PPG attached from the gold standard BioPac. The morphic sensors will continuously measure signals during the study. Routine (standard of care) measurements will be collected. The participant will then undergo an exercise stress test using a supine ergometer. This stress test will be an in line with the hospital's specific Exercise Right Heart Catheter Protocol. Signals will be collected from the morphic sensors during the exercise test and for a period of 5-10 minutes after the completion of the exercise test. The invasive study is estimated to add an additional 20 mins to the standard of care RHC. Once the RHC is completed, all lines will be removed from the participant and all study devices removed.
The standard of care measurements that will be taken include:
• Pulmonary artery pressure (mmHg)
• Cardiac Index (L/min) -
• Pulmonary artery systolic pressure (mmHg)
• Pulmonary artery diastolic pressure (mmHg)
• Pulmonary capillary wedge pressure (mmHg)
• Right atrial pressure (mmHg)
• ECG
• Phonocardiogram sounds
• Pulse Wave Velocity (meters/second)
• Peripheral blood pressure (mmHg)
• Pre-ejection period (milliseconds)
• Central pulse arrival time (milliseconds)
• Peripheral pulse arrival time (milliseconds)
• Central pulse transit time (milliseconds)
• Peripheral pulse transit time (milliseconds)

Participants will be followed up until discharge or 24-hours post RHC completion, whichever comes first (end of study).
Intervention code [1] 325127 0
Diagnosis / Prognosis
Comparator / control treatment
1. Swan Ganz Catheter (SGC) (Right Heart Catheter)
2. Biopac Acquisition Module with associated sensors: ECG, PPG, blood pressure pulse and acoustic sounds
3. SphygmoCor Xcel
4. Echocardiogram
Control group
Active

Outcomes
Primary outcome [1] 333432 0
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Pulse Wave Volocity as compared to the SphygmoCor XCEL device (within a 95% Confidence Interval.)
Timepoint [1] 333432 0
During Invasive and Non-invasive study
Primary outcome [2] 333526 0
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Central Blood Pressure as compared to the SphygmoCor XCEL device (within a 95% Confidence Interval.)
Timepoint [2] 333526 0
During Invasive and Non-invasive study
Primary outcome [3] 333527 0
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Peripheral Blood Pressure as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)
Timepoint [3] 333527 0
During Invasive and Non-invasive study
Secondary outcome [1] 417097 0
*This is an additional primary outcome*
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Pre-Ejection Period as compared to the BioPac device and the Echocardiogram device (within a 95% Confidence Interval.)
Timepoint [1] 417097 0
During Invasive and Non-invasive study
Secondary outcome [2] 417421 0
*This is an additional primary outcome*
That the morphic sensors can accurately record (greater than or equal to 90% value comparison)Heart-carotid Central Pulse Arrival Time as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)
Timepoint [2] 417421 0
During Invasive and Non-invasive study
Secondary outcome [3] 417422 0
*This is an additional primary outcome*
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Heart-Peripheral Pulse Arrival Time as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)
Timepoint [3] 417422 0
During Invasive and Non-invasive study
Secondary outcome [4] 417423 0
*This is an additional primary outcome*
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Aortic-Central Pulse Transit Time as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)
Timepoint [4] 417423 0
During Invasive and Non-invasive study
Secondary outcome [5] 417424 0
*This is an additional primary outcome*
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Aortic-peripheral pulse transit time as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)
Timepoint [5] 417424 0
During Invasive and Non-invasive study

Eligibility
Key inclusion criteria
1. 18-75 years of age.
2. Diagnosed with Heart Failure (New York Heart Association (NYHA) II to IV) for RHC as part of standard medical care.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant is on mechanical ventilation.
2. Participant is receiving cardiac mechanical support.
3. Participant is pregnant or lactating.
4. Inability to place morphic sensors.
5. Participating in a concurrent clinical investigation which has not yet met its primary endpoint, or in the investigator’s opinion, participation in this study would affect the primary endpoint of the concurrent study.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
1/08/2023
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
50
Accrual to date
29
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 23751 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 23752 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 39195 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 39196 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 312891 0
Commercial sector/Industry
Name [1] 312891 0
Medical Monitoring Solutions Pty Ltd
Country [1] 312891 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medical Monitoring Solutions Pty Ltd
Address
Suite 1402B 275 Alfred Street N North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 314570 0
None
Name [1] 314570 0
N/A
Address [1] 314570 0
N/A
Country [1] 314570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312168 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 312168 0
Ethics committee country [1] 312168 0
Australia
Date submitted for ethics approval [1] 312168 0
Approval date [1] 312168 0
20/12/2022
Ethics approval number [1] 312168 0

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

Contacts
Principal investigator
Name 123714 0
Prof David Kaye
Address 123714 0
The Alfred. 55 Commercial Rd, Melbourne VIC 3004
Country 123714 0
Australia
Phone 123714 0
+61 03 9076 3040
Fax 123714 0
+61 03 907 62162
Email 123714 0
D.Kaye@alfred.org.au
Contact person for public queries
Name 123715 0
Neil Anderson
Address 123715 0
Medical Monitoring Solutions. Suite 1403 275 Alfred Street, North Sydney, NSW, 2060.
Country 123715 0
Australia
Phone 123715 0
+61 2 8317 5460
Fax 123715 0
+61 2 8317 5461
Email 123715 0
neil@saiiv.com
Contact person for scientific queries
Name 123716 0
Neil Anderson
Address 123716 0
Medical Monitoring Solutions. Suite 1403 275 Alfred Street, North Sydney, NSW, 2060.
Country 123716 0
Australia
Phone 123716 0
+61 2 8317 5460
Fax 123716 0
+61 2 8317 5461
Email 123716 0
neil@saiiv.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.