ANZCTR - Registration

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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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]