jRCTs042240196招募中不适用
The usefulness of RST-guided management to prevent readmission in chronic heart failure patients at home -A multicenter, single-arm, open-label clinical study - (ITMETHOD-HF-III )
未提供0 个研究点目标入组 80 人开始时间: 2025年3月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 主要终点
- Incidence of hospitalization and cardiac death due to heart failure
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •[First Enrollment]
- •Include patients who meet all the criteria below are included.
- •Patients who understand the purpose of this study and have given their written consent to participate in this study.
- •Patients must be 20 years of age or older when obtaining consent.
- •Patients diagnosed with heart failure according to the Guideline for Diagnosis and Treatment of Acute and Chronic Heart Failure (JCS2017/JHFS2017) (patients with organic and/or functional abnormalities in the heart, decreased cardiac pump function, and symptoms of heart failure)
- •Patients with a history of hospitalization due to exacerbation of heart failure more than once within five years before obtaining consent.
- •Patients who are currently attending an outpatient clinic or who are currently hospitalized but whose investigator has determined that they will be able to attend an outpatient clinic after being discharged.
- •Patients with heart failure symptoms (NYHA cardiac functional classification of II or higher at the time of enrollment).
- •[Second Enrollment]
- •Among the first enrolled patients, include patients who could be measured RST in their home environment.
排除标准
- •[First Enrollment]
- •Exclude patients who meet any of the following criteria.
- •Patients whose bed or futon may be occupied by other people or pets.
- •Patients who are unable to measure respiration regularly for two hours or more at night (23:00-5:00) for three or more days a week due to lifestyle factors, etc.
- •Patients with no spontaneous breathing
- •Patients with obvious chronic obstructive pulmonary disease (hyperinflation of the lung field and lowering and flattening of the diaphragm on chest X-ray).
- •Patients on the supportive ventilation therapy such as Adaptive Servo-Ventilation (ASV) or Continuous Positive Airway Pressure (CPAP) while sleeping.
- •Patients diagnosed as pregnant.
- •Patients with obstructive sleep apnea syndrome as a major disease.
- •Patients with a history of cerebral hemorrhage or stroke regardless of the presence or absence of sequelae.
- •Patients who have or are scheduled to have a ventricular assist device (VAD)
- •Patients on dialysis due to renal failure.
- •Patients with severe deterioration in renal function or liver function.
- •Patients who have been participating in other intervention studies (including clinical trials).
- •Patients diagnosed with dementia.
- •Patients with no capacity to consent.
- •Patients who may not be followed-up during the observational period (78 weeks).
- •Patients who are judged to be inappropriate for this study by investigators.
- •[Second Enrollment]
- •Exclude patients who meet any of the following criteria.
- •Among patients whose RST measurement was insufficient in the first week after body motion sensor installation* and re-measured in the second week, patients whose RST measurement in the second week was less than 5 days or whose average RST was less than 20 seconds or more than 60 seconds.
- •note:Insufficient RST measurement during the first week after installing the body motion sensor refers to cases that fall under any of the following criteria.
- •a) If the RST measurement in the first week after installing the body motion sensor is less than 5 days
- •b) If the average RST in the first week after installing the body motion sensor is less than 20 seconds or more than 60 seconds
- •c) If the RST on the 7th day drops to less than 20 seconds, even if the average RST in the first week after installing the body motion sensor is 20 seconds or more
- •Patients who were hospitalized after the first enrollment (however, if the patient recovers after being hospitalized, it is possible to restart the screening and be assigned a new enrollment number to participate in the study)
- •Patients found to meet the exclusion criteria for the first enrollment after the first enrollment.
- •Patients who are judged to be inappropriate for this study by investigators.
结局指标
主要结局
Incidence of hospitalization and cardiac death due to heart failure
时间窗: from the beginning of study treatment to end of observational period
从研究治疗开始到观察期结束，因心力衰竭导致的住院和心脏性死亡的发生率
次要结局
- Incidence of hospitalization and cardiac death due to heart failure
- Incidence of heart failure events
- Incidence of hospitalization and cardiac death due to heart failure for 60 days after RST decline(60 days after RST decline)
- Incidence of heart failure for 60 days after RST decline(60 days after RST decline)
- Incidence of hospitalization and cardiac death due to heart failure in episodes with RST recovery after RST decline
- Incidence of hospitalization and cardiac death due to heart failure in the group where RST did not decrease
- Incidence of RST recovery for one month after RST decline(one month after RST decline)
- Medical device failure, diseases, etc.
研究者
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