Remote Monitoring for Patients With Aortic Stenosis

Официальное название

Remote Monitoring for Asymptomatic Patients With Moderate to Severe Aortic Valve Stenosis - Remote-AS

Обзор

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.

Первичные конечные точки

• LV hypertrophy [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - Mitral inflow E/A ratio [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - average E/e' ratio [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - septal e' velocity [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - lateral e' velocity [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - left atrial volume index [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Diastolic function - peak diastolic strain rate [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Global longitudinal strain (GLS) [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Myocardial perfusion [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Myocardial energetics index [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]

Вторичные конечные точки (11)

• Physical activity [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• High sensitivity cardiac troponin (hscTNT) [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Proteomics [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Quality-of-Life questionnaire: KCCQ-CSS [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Quality-of-Life questionnaire: EQ-5D-5L [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]
• Quality-of-Life questionnaire: Toronto AS QoL [Срок оценки: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07690748 · 587-25 · 119917

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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