ITMETHOD-HF II

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2020
INTERVENTION: 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. CONDITION: Chronic heart failure 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 INCLUSION 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.
Epistemonikos ID: 22e9c3c0577a0b051f851f557cac5c33f9caef0b
First added on: Aug 24, 2024