Remote Monitoring for Patients With Aortic Stenosis

NCT07690748 | Not Yet Recruiting

• 2 other identifiers: 587-25119917
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (14)

• LV hypertrophy

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

  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

  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

  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.

  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.

  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)

  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)

  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)

  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)

  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)

  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

  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)

  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)

  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)

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

Secondary Outcomes (11)

• Physical activity

  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

  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

  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

  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

  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).

Study Arms (1)

Aortic stenosis

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Ability and willingness to provide written and informed consent and to comply with the requirements of the study.

You may not qualify if:

• 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)
• Known hypersensitivity to adenosine (ever requiring hospital admission with asthma or chronic obstructive pulmonary disease) or gadolinium
• Significant renal impairment (eGFR\<30ml/min/m2)

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: collaborator
• University of Melbourne: collaborator
• The University of Western Australia: collaborator
• Baker Heart and Diabetes Institute: lead
• The Alfred: collaborator
• Monash Medical Centre: collaborator
• Deakin University: collaborator
• La Trobe University: collaborator
• Melbourne Health: collaborator

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Central Study Contacts

Sjoerd Levelt, PhD

CONTACT

+61385321874; sjoerd.levelt@baker.edu.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology, Head of Cardiometabolic Imaging Lab

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: July 8, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share