About this trial

Remote-AS aims to develop a remote digital monitoring cohort of people with AS and use these data to establish a digital twin intervention to personalise risks and benefits, and optimise the time of surgical or transcatheter aortic valve replacement (AVR) referral. Our digital solution will also seek modelling for optimal care for patients to whom AVR is indicated who choose not to undergo the procedure, supporting a patient-selected observational strategy for managing heart failure symptoms, facilitating patient education and self-care.

Objectives of the study are:

* To establish a large-scale interdisciplinary research program to drive implementation of substantial improvements to health care and/or health system effectiveness in patients with aortic stenosis (AS) * To establish a new model of patient-centred management strategy for asymptomatic severe AS to inform the optimal time at which valve intervention should take place * For patients to whom AVR is indicated who choose not to undergo the procedure, to support a patient-selected observational strategy for managing heart failure symptoms * To develop a digital twin with predictive capabilities of artificial intelligence (AI) for guiding the optimal timing of AVR in patients with asymptomatic severe AS

Participants will be patients with asymptomatic moderate to severe native AS (n=160) (based on guideline-recommended diagnosis and care with peak aortic velocity \>3.5m/sec).

Participants will undergo:

Wearables: collection of physiological (e.g., blood pressure, heart rate, rhythm) and behavioural (physical activity) data through a wearable device ('smart watch'), collected through the comprehensive remote heart health monitoring and automated feedback delivery system app SMART.

Patient reported outcome measures: KCCQ-CSS; EQ-5D-5L index score; "Toronto Aortic Stenosis" quality of life questionnaires.

Advanced cardiovascular imaging: Cardiovascular magnetic resonance (CMR) imaging; 31phosphorus magnetic resonance spectroscopy (31P-MRS); proton magnetic resonance spectroscopy (1H-MRS); echocardiography.

Comprehensive plasma proteome profiling: Plasma proteomic preparation coupled with the Orbitrap Astral mass spectrometer.

Recording of clinical outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥18 years of age

Suitable to undergo MRI scans

With asymptomatic moderate to severe native AS (based on guideline-recommended diagnosis and care)

Eligible for Medicare

Disqualifiers

Serious comorbidity other than AS that limits the life expectancy (<2 years), or affects study participation or outcome (severe frailty and mobility issues [Rockwood frailty score >6], severe kidney disease eGFR<30, infiltrative cardiomyopathy)

Known heart failure or reduced left ventricular ejection fraction (<50%)

Moderate or above valvular pathology other than AS

Contra-indications to CMR (including presence of foreign metallic bodies)

Trial population

Potential participants will be identified by their cardiologist or cardiothoracic surgeon at high-volume Australian centres in Melbourne.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

160 Participants

are grouped into 1 trial group

Group A: Aortic stenosis

Trial outcomes

Primary outcomes

1

LV hypertrophy

Left ventricular mass index\[g/m2\], imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

Time frame

6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

2

Diastolic function - Mitral inflow E/A ratio

Mitral inflow E/A ratio, imaging endpoint on echocardiography

Time frame

6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

3

Diastolic function - average E/e' ratio

Average E/e' ratio, imaging endpoint on echocardiography

Time frame

6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

4

Diastolic function - septal e' velocity

Septal e' velocity, imaging endpoint on echocardiography.

Time frame

6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

Secondary outcomes

1

Physical activity

Digital endpoint measured from wearable devices and processed via the SMART architecture

Time frame

Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

2

Blood pressure

Digital endpoint measured from wearable devices and processed via the SMART architecture

Time frame

Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

3

Heart rhythm

Digital endpoint measured from wearable devices and processed via the SMART architecture

Time frame

Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

4

Heart rate variability

Digital endpoint measured from wearable devices and processed via the SMART architecture

Time frame

Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

Locations

This trial has no locations.

Remote Monitoring for Patients With Aortic Stenosis

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts