ITMETHOD-HF II

JRCT ID: jRCT2052190111

Registered date:20/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic heart failure
• Date of first enrollment: 29/10/2019
• Target sample size: 80
• Study type: Interventional
• Intervention(s): In the RST monitoring group, the investigators should check RSTs of patients once a day besides the regular disease management as in the usual treatment group and recommend patients to visit hospital when they find a continuous decline in RST.

Outcome(s)

• Primary Outcome: Incidence of heart failure death or exacerbation of heart failure requiring hospitalization during run-in period (52 weeks).

Secondary Outcome

Evaluation of Efficacy
1) In the usual treatment group, sensitivity and specificity of RST for exacerbation of heart failure
2) Cumulative readmission rate of heart failure
3) In the RST monitoring group, comparison of readmission and mortality rate between patients with recovery and those without recovery after treatment for reduced RST conditions
4) QOL score changes from the beginning of protocol treatment to end of observational period (52 weeks)
5) Cost-benefit analysis

Evaluation of Safety
1) Adverse events
2) Medical device failure

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who provided written informed consent to participate this trial.
2) Patients must be 20 years of age or older when obtaining their consents.
3) Patients who have been diagnosed with heart failure according to the Guideline for Diagnosis and Treatment of Acute and Chronic Heart Failure (JCS2017/JHFS2017)
4) Patients with a history of hospitalization due to worsening heart failure more than once within five years before obtaining their consents.
5) Patients who can visit outpatient department.
6) Patients with New York Heart Association Functional Classification of II, III or IV.

Exclude criteria

1) Patients who may sleep with another person or pets in the same bed.
2) Patients who may not sleep more than two hours at night for more than three days a week regularly on their bed due to factors such as lifestyle.
3) Patients who are unable to breathe on their own.
4) Patients with chronic obstructive pulmonary disease.
5) Patients on the supportive ventilation therapy such as Adaptive Servo-Ventilation or continuous Positive Airway Pressure during the night.
6) Patients who are pregnant.
7) Patients who do not use highly effective contraception during the run-in period.
8) Patients with obstructive sleep apnea syndrome as a major disease.
9) Patients with sequelae due to cerebrovascular disease.
10) Patients on dialysis due to renal failure.
11) Patients with severe deterioration in kidney or liver function.
12) Patients who have been participating in other intervention studies including clinical trials.
13) Patients with dementia.
14) Patients with inability to provide informed consent.
15) Patients who may not be followed-up during run-in period (52 weeks).
16) Patients who are judged to be inappropriate for this trial by investigators.

Related Information

• Primary Sponsor: Sawa Yoshiki
• Secondary Sponsor: Asanoi Hidetsugu