Validating the Ability for Early Recognition of Worsening Heart Failure by a System Technology of Automated Prediction From Multi-sensor Data: A Prospective, Open-label, Single-arm, International, Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- Chronolife
- 入组人数
- 552
- 主要终点
- Detection of worsening heart failure (WHF) event
研究概览
简要总结
The study is a multi-center, prospective, non-randomized, observational study to collect data to develop and validate a machine learning algorithm for early detection of worsening heart failure events using multi-parametric sensor data from wearable data capture device The VESTA study will enroll up to 552 subjects in up to 25 centers in order to collect data on a total of at least 56 worsening heart failure events (independently adjudicated hospitalizations or unscheduled intravenous administration of decongestive drugs).The duration of follow-up per participant will be between 3-6 months.
详细描述
The study is an international, multicenter, prospective, open-label, non-randomized single group study, with no control group.
The study has 2 phases: the first phase is to train and develop the automated learning algorithm; the second phase is to validate the algorithm.
The participants will be assigned into two cohorts:
- Cohort 1 will provide the data to be used for algorithm development and training.
- Cohort 2 will provide data to be used for algorithm validation.
It has been estimated that approximately 276 subjects are required for each cohort in order to accumulate the minimum number of cases for the study's primary objective. Sequential enrolment will be implemented by regional blocks according to an estimation of the regional distribution of subjects.The sample size and regional distribution of subjects are estimates and the study is endpoint driven to achieve at least 28 WHF events with corresponding analyzable device data. Fewer subjects may be enrolled should the required number of events be acquired at a faster rate than calculated and the regional proportions of subjects may vary according to regional enrollment rates.
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
- •18 years of age and above
- •New York Heart Association(NYHA) functional class II-IV
- •Reduced ejection fraction (HFrEF) with left ventricular ejection fraction (LVEF) ≤40%
- •History of chronic HF as evidenced by
- •LVEF ≤40% measured at least 30 days before enrollment
- •N-terminal-pro hormone brain-type natriuretic peptide (NT-proBNP) > 500 pg/mL OR brain-type natriuretic peptide (BNP) >150 pg/mL; tested no longer than one month prior to inclusion.
- •At increased risk for HF decompensation as defined by
- •currently inpatient with hospital admission due to HF decompensation (acute on chronic heart failure), or
- •history of hospitalization for HF decompensation in the last 6 months
- •Understands the study requirements and the study procedures and provides written informed consent before any trial-specific tests or procedures are performed
排除标准
- •Known allergy to any component of the study device (cotton, elastane, polyester)
- •Current HF hospitalization due to acute de novo heart failure
- •Current HF decompensation due to triggers like surgery or perioperative complications, pulmonary embolic episode or acute myocardial infarction
- •Severe chronic kidney disease with glomerular filtration rate (GFR) <30 ml/ min/1.73 m2 and/or renal replacement therapy
- •Evidence of hepatic disease as determined by any one of the following: serum glutamic-oxaloacetic transaminase (SGOT/AST) or serum glutamic-pyruvic transaminase (SGPT/ALT) values exceeding 3x upper limit of normal, bilirubin >1.5 mg/dl
- •Body mass index (BMI)>35 kg/m2
- •Planned surgery or other procedures within 6 months after the inclusion
- •Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- •Receiving mechanical circulatory support
- •Candidates on heart transplant list
- •Factors or conditions, that according to investigator assessment may affect compliance with protocol or cause confound data interpretation. Examples may include but are not limited to:
- •Cardiac conditions or interventions such acute coronary syndrome, major cardiovascular surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) or implantation of a cardiac resynchronization therapy (CRT) device within 3 months prior to inclusion, or having certain implanted cardiac devices that affect cardiac condition or circulation,
- •Other serious medical illness (e.g., cancer) with estimated life expectancy of less than 12 months.
- •Current problems with substance addiction
- •Participating in another investigational drug or device clinical trial
- •Pregnant or nursing
结局指标
主要结局
Detection of worsening heart failure (WHF) event
时间窗: 6 months
Sensitivity and Specificity of detection of WHF event by a machine-learning algorithm system using multi-parametric data captured by non-invasive telemonitoring. WHF event definition: * Any hospital admission for WHF(e.g. due to new or progressive symptoms/signs of decompensated HF including significant weight gain, worsening dyspnea or fatigue, newly elevated jugular venous pressure, new cardiac S3 gallop rhythm, the development of pulmonary rales, hepatic congestion or lower extremity edema), OR * Any administration of intravenous HF therapy in an unscheduled setting (e.g. clinic/office/emergency department, ED).
次要结局
- Other healthcare encounters do not meet criteria of WHF event, points a, b and c but are deemed related to HF(6 months)
- Acceptability and usability of study data capture device assessed by Study Ergonomics and Usability Questionnaire(6 months)
- Outpatient health encounters leading to changes or adjustments of oral HF medication(6 months)
- Hospitalizations for HF that did not meet WHF(6 months)
- Number of Adverse and Serious Adverse Events known to be associated with wearable devices with sensors(Occuring during the 6 month follow-up)
- Frequency and duration of study data capture device assessed by Study Frequency and duration of use Questionnaire(6 months)
- HF-hospitalization in number of days(6 months)