An observational study in Aortic Stenosis, sponsored by Baker Heart and Diabetes Institute. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Baker Heart and Diabetes Institute · Observational
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:
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.
Potential participants will be identified by their cardiologist or cardiothoracic surgeon at high-volume Australian centres in Melbourne.
Exclusion Criteria:
Patients with asymptomatic moderate to severe native AS (n=160) (based on guideline-recommended diagnosis and care with peak aortic velocity \>3.5m/sec).
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
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
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
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
Diastolic function - lateral e' velocity
Lateral e' velocity, imaging endpoint on echocardiography.
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Diastolic function - left atrial volume index
Left atrial volume index, 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
Diastolic function - peak diastolic strain rate
Peak diastolic strain rate, 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
Global longitudinal strain (GLS)
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
Myocardial perfusion
Rest and adenosine stress CMR-measured myocardial blood flow and myocardial perfusion reserve 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
Myocardial energetics index
31P-MRS-measured phosphocreatine to ATP ratio, imaging endpoint on cardiovascular magnetic resonance spectroscopy (MRS)
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Myocardial triglyceride content
Imaging endpoint as measured by 1H-MRS
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Myocardial fibrosis index - extra cellular volume [ECV] fraction
Extra cellular volume \[ECV\] fraction, tissue characteristic 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
Myocardial fibrosis index - index-ECV
Index-ECV, 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
Myocardial fibrosis index - scar percentage
Late gadolinium enhancement imaging-assessed scar percentage, 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
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).
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).
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).
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).
Oxygen saturation
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).
NTproBNP
Blood biomarker
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
High sensitivity cardiac troponin (hscTNT)
Blood biomarker
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Proteomics
Advanced, label-free quantitative mass spectrometry-based proteomics blood biomarkers
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Quality-of-Life questionnaire: KCCQ-CSS
Patient-reported outcome measure via Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score \[KCCQ-CSS\]
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Quality-of-Life questionnaire: EQ-5D-5L
Patient-reported outcome measure via EuroQoL 5-dimension 5-level \[EQ-5D-5L\] index score
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Quality-of-Life questionnaire: Toronto AS QoL
Patient-reported outcome measure via "Toronto Aortic Stenosis" quality of life questionnaire
Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
No study locations are listed for this record.
Plan to share: Yes — Upon publications, the investigators envisage allowing access to the data in a systematic manner through a platform dedicated to sharing scientific research data (e.g., ShareFile). Specific datasets will be made available after publications by us and sharing of data is intended to be determined on a case-by-case basis at the discretion of the Principal Investigator, and provided agreement to preserve the confidentiality of the information. All data will be shared in a non-identifiable format. Data will be collected, stored and shared in accordance with National Statement 3.1.44 and 3.1.55. If journals request that the research team make raw data available, the anonymised raw non-identifiable data will be shared in a systematic manner through a platform dedicated to sharing scientific research data (e.g., ShareFile). The participant information/consent form includes this information for participants following guidelines from the Australian Research Data Commons (ARDC) guide.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Baker Heart and Diabetes Institute