FF01-01 Study
Active, not recruiting
- Conditions
- Elderly patients with chronic heart failure
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 430
Inclusion Criteria
Patients meeting all of the following criteria will be selected:
- Patients diagnosed with chronic heart failure based on the diagnostic criteria outlined in the Japanese Circulation Society's Guidelines for the Management of Acute and Chronic Heart Failure.
- Patients aged 75 years or older at the time of consent.
- Patients who have received a thorough explanation of this clinical trial and provided written informed consent.
Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from this clinical trial:
- Patients unable to walk according to instructions.
- Patients deemed unsuitable for the clinical trial at the discretion of the physician.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Evaluation of error between the Clinical Frailty Scale (CFS) calculated by investigational devices and labeling results by Japanese Circulation Society board-certified cardiologists Assessed by QWK
- Secondary Outcome Measures
Name Time Method Evaluation of error in CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists 评估研究医疗器械计算的CFS与日本循环学会认证心脏病专家标注结果之间的误差(通过QWK评估)
Agreement rate for each CFS between CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists 研究医疗器械计算的CFS与日本循环学会认证心脏病专家标注结果之间每个CFS的一致性率
Evaluation of differences in results from repeated tests 评估重复测试结果的差异(同一时间对同一患者进行的多次测试)
Agreement rate for each CFS between CFS calculated by investigational medical devices at each medical institution and labeling results by Japanese Circulation Society board-certified cardiologists 各医疗机构研究医疗器械计算的CFS与日本循环学会认证心脏病专家标注结果之间每个CFS的一致性率
Frequency of misclassification by two or more grades of CFS calculated by the application compared to labeling results by Japanese Circulation Society board-certified cardiologists 应用程序计算的CFS与日本循环学会认证心脏病专家标注结果相比,两个或更多等级分类错误的频率