jRCT2052260100招募中不适用
Smartwatch-based Predictive and Interventional Research in Ambulatory Chronic Heart Failure Patients
未提供0 个研究点目标入组 132 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •At Initial Registration
- •Subjects must meet all of the following criteria
- •1.Subjects aged 18 years or older at the time of obtaining informed consent, regardless of sex.
- •2.Subjects who have voluntarily provided written informed consent for participation in this clinical trial.
- •3.Subjects with chronic heart failure classified as Stage C or D according to the ACCF/AHA heart failure staging system.
- •4.Subjects with NT-proBNP at least 900 pg/mL at screening.
- •5.Subjects classified as New York Heart Association (NYHA) Class II or III.
- •6.Subjects who are either outpatients, or currently hospitalized due to heart disease but are considered by the investigator or sub-investigator to be capable of outpatient visits after discharge.
- •7.Subjects who are able to understand Japanese used in the investigational device.
- •8.Subjects who are ambulatory without assistance (use of assistive devices such as a cane is permitted).
- •At Secondary Registration (Intervention group only)
- •Subjects must meet all of the following criteria
- •1.Subjects who have completed the training (1 within 7 days)
- •and have been assessed by trial staff using the device training checklist to be
- •able to use the investigational device without problems.
- •( After initial registration, a training period of up to 7 days shall be provided when the subject takes the investigational device home and initiates use.)
- •2.Subjects for whom measured data have been confirmed for two consecutive days, satisfying all of the following
- •Data on symptoms, body weight, and heart sounds have been recorded for two consecutive days
- •Activity data of at least 24.5 METsh have been recorded
- •Heart sounds analyzable by the investigational device have been successfully obtained
排除标准
- •At Initial Registration
- •Subjects who meet any of the following criteria shall be excluded
- •1.Subjects classified as New York Heart Association (NYHA) Class IV.
- •2.Subjects in whom auscultation is difficult due to implanted devices (e.g., port, pacemaker, breast implant) or conditions such as ulcers in the area from the sternum to the left nipple.
- •3.Subjects using implantable devices with heart failure monitoring functions (e.g., OptiVol TM).
- •4.Subjects who have undergone mechanical heart valve replacement.
- •5.Subjects who are unable to continuously wear the investigational device on the wrist during daytime.
- •6.Subjects diagnosed with dementia.
- •7.Subjects for whom the physician determines that heart failure is predominantly right-sided.
- •8.Subjects with adult congenital heart disease (excluding those after ASD or VSD closure).
- •9.Subjects in whom adequate heart sounds cannot be confirmed by auscultation by a physician.
- •10.Subjects in whom a third heart sound (S3) is detectable at screening.
- •11.Subjects with serum creatinine at least 3.0 mg/dL.
- •12.Subjects receiving dialysis for renal failure.
- •13.Subjects who are currently participating in another interventional study (including clinical trials) within 3 months prior to enrollment.
- •14.Subjects with malignant tumors (except for those with no recurrence for at least 5 years).
- •15.Subjects with liver cirrhosis classified as Child Pugh Grade B or higher.
- •16.Subjects with progressive diseases expected to limit survival to less than 1 year (e.g., liver failure).
- •17.Pregnant or possibly pregnant women, or breastfeeding women.
- •18.Subjects deemed by the investigator or sub investigator to be inappropriate for participation in this clinical trial.
- •At Secondary Registration (Intervention group only)
- •Subjects who meet any of the following criteria shall be excluded
- •1.Subjects who are hospitalized between initial and secondary registration
- •(However, if the subject recovers after hospitalization, re-screening may be performed and participation is allowed with assignment of a new subject identification number).
- •2.Subjects who are found to meet any of the exclusion criteria for initial registration after enrollment.
- •3.Subjects whose loaned smartphone indicates out of service area at home.
- •4.Subjects deemed by the investigator or sub-investigator to be inappropriate for participation in this clinical trial.
研究者
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