Remote Monitoring for Patients With Aortic Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Aortic Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remote Monitoring for Asymptomatic Patients With Moderate to Severe Aortic Valve Stenosis - Remote-AS
Overview
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.
Primary outcome measures
- LV hypertrophy [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - Mitral inflow E/A ratio [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - average E/e' ratio [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - septal e' velocity [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - lateral e' velocity [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - left atrial volume index [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Diastolic function - peak diastolic strain rate [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Global longitudinal strain (GLS) [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Myocardial perfusion [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Myocardial energetics index [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
Secondary outcome measures (11)
- Physical activity [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 [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 [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 [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 [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 [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- High sensitivity cardiac troponin (hscTNT) [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Proteomics [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Quality-of-Life questionnaire: 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 [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
- Quality-of-Life questionnaire: Toronto AS QoL [Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07690748 · 587-25 · 119917