FF01-01 Study

Performance validation study of the Frailty Finder in elderly patients with heart failure

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2012240059

Enrollment

430

Registered

2024-12-12

Start date

2024-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly patients with chronic heart failure

Interventions

Two videos of walking along a designated course are recorded, and the Clinical Frailty Scale (CFS) is analyzed based on the obtained image data.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients meeting all of the following criteria will be selected: 1. 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. 2. Patients aged 75 years or older at the time of consent. 3. Patients who have received a thorough explanation of this clinical trial and provided written informed consent.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this clinical trial: 1. Patients unable to walk according to instructions. 2. Patients deemed unsuitable for the clinical trial at the discretion of the physician.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Evaluation of error in CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists (assessed by QWK). 2. Agreement rate for each CFS between CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists. 3. 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. 4. 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. 5. Evaluation of differences in results from repeated tests (multiple tests conducted at the same timing for the same patient).	—

Measure

Time frame

1. Evaluation of error in CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists (assessed by QWK). 2. Agreement rate for each CFS between CFS calculated by investigational medical devices and labeling results by Japanese Circulation Society board-certified cardiologists. 3. 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. 4. 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. 5. Evaluation of differences in results from repeated tests (multiple tests conducted at the same timing for the same patient).

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Contacts

Public ContactToshiyuki Nagai

Hokkaido University Hospital

nagai@med.hokudai.ac.jp+81-11-716-1161

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026