Home-based heart faiure study

JRCT ID: jRCT1072240118

Registered date:25/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 25/02/2025
• Target sample size: 60
• Study type: Interventional
• Intervention(s): A phonocardiogram examination will be performed on study participants in the intervention group using the AMI-SSS01 phonocardiogram examination device during the visit. The AMI-SSS01 is used to record sound information at four points on the anterior thoracic region for 8 seconds each.

Outcome(s)

Primary Outcome

Time from allocation to the occurrence of the following composite endpoints of heart failure hospitalization or cardiovascular death.
- Heart failure hospitalization: Patient was hospitalized with heart failure as a primary or secondary condition after being transferred to a tertiary care hospital following a heart failure exacerbation event. (Include patients who had heart failure as a primary condition even if it was triggered by infection, thyroid disease, anemia, etc.)
- Cardiovascular deaths: Patients who were transported to a higher-level medical facility after a heart failure exacerbation event and were hospitalized for heart failure but died, or who died after a heart failure exacerbation event and were cared for in a home health care setting.

Secondary Outcome

Number of heart failure exacerbation events during the observation period. Since there is no established definition of an exacerbation event, heart failure exacerbation events are defined in two ways: (1) clinical definition only and (2) clinical definition and abnormal laboratory findings.
The clinical definition of a heart failure exacerbation event is the presence of two or more of the following symptoms of heart failure exacerbation or abnormal physical findings Laboratory abnormalities are defined as an increase in serum NT-proBNP or abnormal echocardiographic or chest radiographic findings.
- Symptoms of worsening heart failure
- Physical examination findings in worsening heart failure
- Abnormal laboratory findings in exacerbation of heart failure

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: (1) Symptomatic heart failure patients 65 years of age or older who are receiving home-visit treatment at the implementing institution (2) Patients who have obtained written consent for participation in the study from the patients themselves or their surrogate(s)

Exclude criteria

(1) Patients receiving maintenance dialysis
(2) Patients with a terminal diagnosis of a disease other than heart failure for which the prognosis is less than one month
(3) Those participating in a clinical trial or other clinical research

Related Information

• Primary Sponsor: Yamanashi Hirotomo