Real Life Multimarker Monitoring in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 27
- 试验地点
- 10
- 主要终点
- Daily Steps Count
研究概览
简要总结
The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.
详细描述
Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed before any study-specific procedure
- •Men or women aged 45 years and older
- •Established diagnosis of chronic heart failure NYHA class II-IV
- •Worsening heart failure requiring hospitalization for the initiation of intensification of heart failure therapy with at least one of the following: a) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) OR BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation); OR b) Radiographic evidence of pulmonary congestion (interstitial edema, pulmonary venous hypertension, vascular congestion, pleural effusion); OR c) Catheterization documented elevated filling pressures at rest (left ventricular end-diastolic pressure ≥15 mmHg or pulmonary capillary wedge pressure ≥ 20 mmHg) or with exercise (pulmonary capillary wedge pressure ≥ 25 mmHg) OR Ambulatory patients with a history of heart failure on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks and at least one of the following: a) Hospitalization for heart failure within the past 12 months; OR b) BNP ≥ 100 pg/mL or NT-proBNP ≥ 400 pg/mL (sinus rhythm) or BNP ≥ 300 pg/mL or NT-proBNP ≥ 1200 pg/mL (atrial fibrillation)
- •For HFrEF only: EF ≤35% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion
- •For HFpEF only: EF ≥45% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within 12 months prior to study inclusion
- •Willingness to wear the DynaPort Move Monitor accelerometer belt and VitalPatch Biosensor during the trial
- •Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process
- •Exclusion Criteria
- •Inability to comply with planned study procedures or to comply with study protocol requirements; this includes completing required data collection, and attending required follow up study visits
- •Hemoglobin < 8.0 g/dl
- •Acute coronary syndrome or percutaneous coronary intervention within 3 months prior to informed consent
- •Listing for heart transplantation and / or anticipated implantation of a ventricular assist device
- •Inability to exercise: wheelchair / scooter / walker dependent; dependent on supplemental oxygen
- •Known clinically significant persistent coronary ischemia (based on medical history, a preexisting or a recent clinical stress test)
- •HF is not the primary factor limiting activity within the last three months as indicated by the patient affirming #1, #2 or #3 of the following questionnaire: My ability to be active is most limited by: #1 - Joint, foot, leg, hip or back pain; #2 - Unsteadiness or dizziness impairing daily mobility; #3 - Lifestyle, weather, or I just don't like to be active
- •Occurrence of any of the following within 3 months prior to informed consent: Myocardial infarction, Hospitalization for unstable angina, Stroke or transient ischemic attack, Coronary artery bypass graft (CABG), Percutaneous coronary intervention (PCI), Implantation of a cardiac resynchronization therapy device (CRTD), Major surgery (that could interfere with patients' ability to exercise)
- •PCI, CABG or implantation of a CRTD planned between randomization and Visit 4
- •Subject who cannot tolerate placement of external patch monitor on chest in the proposed location (ECG lead II orientation)
- •Subject with known allergies or hypersensitivities to adhesives or hydrogels
- •Severe uncorrected valvular heart disease
- •Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation)
- •Severe pulmonary disease with any of the following: Requirement of continuous (home) oxygen or History of chronic obstructive pulmonary disease ≥ GOLD III
- •Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s)
- •Any condition or therapy, which would make the patient unsuitable for the study, or life expectancy less than 12 months (e.g. active malignancy)
- •Heavy alcohol consumption or the use of illicit drugs that, in the opinion of the investigator, may interfere with the patient's safety and / or compliance
- •Patients who regularly (> 1x per week) swim, do water aerobics or go to the sauna, unwilling to omit this activity while needing to wear the study specific medical devices
- •Active myocarditis
- •Primary hypertrophic cardiomyopathy
- •Constrictive pericarditis or pericardial tamponade
- •Close affiliation with the investigational site, e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site)
- •Previous participate in the study
排除标准
- 未提供
结局指标
主要结局
Daily Steps Count
时间窗: At Day 9 and Day 77
Daily steps count was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Duration of Daily Physical Activity
时间窗: At Day 9 and Day 77
Duration of daily physical activity was measured with DynaPort Move Monitor device.
Daily Physical Activity Level
时间窗: At Day 9 and Day 77
Movement intensity of an activity, which was the average body acceleration (g) during this activity, was measured with DynaPort Move Monitor device and evaluated as daily physical activity level (PAL). Higher values indicate higher physical activity level and intensity.
Duration of Daily Physical Activity Measured With VitalPatch Biosensor
时间窗: Up to Day 84
Duration of daily physical activity was collected and measured with VitalPatch biosensor.
Total Daily Energy Expenditure
时间窗: At Day 9 and Day 77
Total daily energy expenditure was measured with DynaPort Move Monitor device and evaluated to reflect the amount of daily physical activity.
Time Duration Per Activity Status
时间窗: At Day 9 and Day 77
Time duration per activity status was measured with DynaPort Move Monitor device and evaluated to reflect the intensity of daily physical activity. Physical Activity intensities use absolute aerobic intensity in terms of Metabolic Equivalent of Task (MET), which is a physiological concept expressing the energy cost of a physical activity as a multiple of Basal Metabolic Rate (BMR). By convention, 1 MET is considered as the resting metabolic rate obtained during quiet sitting. According to the American College of Sports Medicine (ACSM) thresholds for adults: Light-intensity activities are defined as 1.1 MET to 2.9 METs; Moderate-intensity activities are defined as 3.0 to 5.9 METs; Vigorous-intensity activities are defined as 6.0 METs or more.
Amount of Daily Physical Activity Measured With VitalPatch Biosensor
时间窗: Up to Day 84
Amount of daily physical activity was collected and measured with VitalPatch biosensor.
Intensity of Daily Physical Activity Measured With VitalPatch Biosensor
时间窗: Up to Day 84
Intensity of daily physical activity was collected and measured with VitalPatch biosensor.
次要结局
- Sleep Patterns(Up to Day 84)
- Growth Differentiation Factor 15 (GDF 15)(At Day 9 and Day 84)
- Left Ventricular Ejection Fraction(At Day 84)
- Left Atrial End Systolic Volume Index(At Day 84)
- Tricuspid Annular Plane Systolic Excursion(At Day 84)
- 6-minute Walking Distance (6MWD)(At Day 84)
- Sleep Movements(Up to Day 84)
- Galectin-3(At Day 9 and Day 84)
- Quality of Life as Measured With the Kansas City Cardiomyopathy Questionnaire Score(At Day 9 and Day 84)
- Sit-to-stand Behaviour(Up to Day 84)
- Quality of Life as Measured With the PRO - Activity Scores(At Day 9 and Day 77)
- Human Interleukin-1 Receptor 4 / ST2 (sST2)(At Day 9 and Day 84)
- Human Insulin-like Growth Factor Binding (IGFBP7)(At Day 9 and Day 84)
- Left Ventricular End-diastolic Volume(At Day 84)
- Left Atrial End-systolic Volume(At Day 84)
- Mitral Septal Annulus Early Diastolic Peak Velocity(At Day 84)
- Heart Rate Variability (HRV) Derived From ECG(Up to Day 84)
- Number of Participants Per NYHA Classification by Visit(At Day 9 and Day 84)
- Quality of Life as Measured With the PRO - Change in Activities and Symptoms(At Day 9 and Day 77)
- Copeptin(At Day 9 and Day 84)
- N-terminal Propeptide of BNP (NT-proBNP)(At Day 9 and Day 84)
- High Sensitive Troponin T (hsTRT)(At Day 9 and Day 84)
- Blood Pressure(At Day 9, Day 77 and Day 84)
- Heart Rate(At Day 9, Day 77 and Day 84)
- Interventricular Septal Wall Thickness(At Day 84)
- Diameter of the Left Ventricle in Diastole(At Day 84)
- Diameter of the Left Ventricle in Systole(At Day 84)
- Mitral Peak Velocity of Late Filling (A)(At Day 84)
- Pressure Gradient of Tricuspid Valve(At Day 84)
- Right Atrial Mean Pressure(At Day 84)
- Left Ventricular End-systolic Volume(At Day 84)
- Mitral Peak Velocity of Early Filling (E)(At Day 84)
- Mitral Lateral Annulus Early Diastolic Peak Velocity(At Day 84)