Remote Monitoring for Asymptomatic Patients With Moderate to Severe Aortic Valve Stenosis - Remote-AS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 主要终点
- LV hypertrophy
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
结局指标
主要结局
LV hypertrophy
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Left ventricular mass index\[g/m2\], imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Diastolic function - Mitral inflow E/A ratio
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Mitral inflow E/A ratio, imaging endpoint on echocardiography
Diastolic function - average E/e' ratio
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Average E/e' ratio, imaging endpoint on echocardiography
Diastolic function - septal e' velocity
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Septal e' velocity, imaging endpoint on echocardiography.
Diastolic function - lateral e' velocity
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Lateral e' velocity, imaging endpoint on echocardiography.
Diastolic function - left atrial volume index
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Left atrial volume index, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Diastolic function - peak diastolic strain rate
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Peak diastolic strain rate, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Global longitudinal strain (GLS)
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Myocardial perfusion
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Rest and adenosine stress CMR-measured myocardial blood flow and myocardial perfusion reserve imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Myocardial energetics index
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
31P-MRS-measured phosphocreatine to ATP ratio, imaging endpoint on cardiovascular magnetic resonance spectroscopy (MRS)
Myocardial triglyceride content
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Imaging endpoint as measured by 1H-MRS
Myocardial fibrosis index - extra cellular volume [ECV] fraction
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Extra cellular volume \[ECV\] fraction, tissue characteristic imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Myocardial fibrosis index - index-ECV
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Index-ECV, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
Myocardial fibrosis index - scar percentage
时间窗: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR
Late gadolinium enhancement imaging-assessed scar percentage, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)
次要结局
- 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).)
- NTproBNP(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
- High sensitivity cardiac troponin (hscTNT)(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
- Proteomics(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
- Quality-of-Life questionnaire: KCCQ-CSS(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
- Quality-of-Life questionnaire: EQ-5D-5L(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
- Quality-of-Life questionnaire: Toronto AS QoL(6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR)
研究者
Eylem Levelt
Professor of Cardiology, Head of Cardiometabolic Imaging Lab
Baker Heart and Diabetes Institute