The usefulness of RST-guided management to prevent readmission in chronic heart failure patients at home -A multicenter, single-arm, open-label clinical study - (ITMETHOD-HF-III )
ITMETHOD-HF-III (ITMETHOD-HF-III )
Kinugawa Koichiro
University of Toyama
2630 Sugitani Toyama Toyama 930-0194
+81-76-434-2315
kinugawa@med.u-toyama.ac.jp
Imamura Teruhiko
Toyama University Hospital
2630 Sugitani Toyama Toyama 930-0194
+81-76-434-7297
te.imamu@gmail.com
Not Recruiting
Feb. 17, 2025
Mar. 12, 2025
80
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
[First Enrollment]
Include patients who meet all the criteria below are included.
1) Patients who understand the purpose of this study and have given their written consent to participate in this study.
2) Patients must be 20 years of age or older when obtaining consent.
3) Patients diagnosed with heart failure according to the Guideline for Diagnosis and Treatment of Acute and Chronic Heart Failure (JCS2017/JHFS2017) (patients with organic and/or functional abnormalities in the heart, decreased cardiac pump function, and symptoms of heart failure)
4) Patients with a history of hospitalization due to exacerbation of heart failure more than once within five years before obtaining consent.
5) Patients who are currently attending an outpatient clinic or who are currently hospitalized but whose investigator has determined that they will be able to attend an outpatient clinic after being discharged.
6) Patients with heart failure symptoms (NYHA cardiac functional classification of II or higher at the time of enrollment).
[Second Enrollment]
Among the first enrolled patients, include patients who could be measured RST in their home environment.
[First Enrollment]
Exclude patients who meet any of the following criteria.
1) Patients whose bed or futon may be occupied by other people or pets.
2) Patients who are unable to measure respiration regularly for two hours or more at night (23:00-5:00) for three or more days a week due to lifestyle factors, etc.
3) Patients with no spontaneous breathing
4) Patients with obvious chronic obstructive pulmonary disease (hyperinflation of the lung field and lowering and flattening of the diaphragm on chest X-ray).
5) Patients on the supportive ventilation therapy such as Adaptive Servo-Ventilation (ASV) or Continuous Positive Airway Pressure (CPAP) while sleeping.
6) Patients diagnosed as pregnant.
7) Patients with obstructive sleep apnea syndrome as a major disease.
8) Patients with a history of cerebral hemorrhage or stroke regardless of the presence or absence of sequelae.
9) Patients who have or are scheduled to have a ventricular assist device (VAD)
10) Patients on dialysis due to renal failure.
11) Patients with severe deterioration in renal function or liver function.
12) Patients who have been participating in other intervention studies (including clinical trials).
13) Patients diagnosed with dementia.
14) Patients with no capacity to consent.
15) Patients who may not be followed-up during the observational period (78 weeks).
16) Patients who are judged to be inappropriate for this study by investigators.
[Second Enrollment]
Exclude patients who meet any of the following criteria.
1) Among patients whose RST measurement was insufficient in the first week after body motion sensor installation* and re-measured in the second week, patients whose RST measurement in the second week was less than 5 days or whose average RST was less than 20 seconds or more than 60 seconds.
note:Insufficient RST measurement during the first week after installing the body motion sensor refers to cases that fall under any of the following criteria.
a) If the RST measurement in the first week after installing the body motion sensor is less than 5 days
b) If the average RST in the first week after installing the body motion sensor is less than 20 seconds or more than 60 seconds
c) If the RST on the 7th day drops to less than 20 seconds, even if the average RST in the first week after installing the body motion sensor is 20 seconds or more
2) Patients who were hospitalized after the first enrollment (however, if the patient recovers after being hospitalized, it is possible to restart the screening and be assigned a new enrollment number to participate in the study)
3) Patients found to meet the exclusion criteria for the first enrollment after the first enrollment.
4) Patients who are judged to be inappropriate for this study by investigators.
20age old over
No limit
Both
Chronic heart failure repeatedly hospitalized despite treatment performed under guidelines
The principal investigators (co-investigators) check the RST of the patients who have the medical device installed once a day on weekdays and recommend patients to visit hospital if RST meets the criteria for RST decline, and perform RST-guided treatment.
Incidence of hospitalization and cardiac death due to heart failure from the beginning of study treatment to end of observational period.
Efficacy:
1) Incidence of hospitalization and cardiac death due to heart failure
2) Incidence of heart failure events (hospitalization/cardiac death and emergency outpatient visit due to heart failure)
3) Incidence of hospitalization and cardiac death due to heart failure for 60 days after RST decline
4) Incidence of heart failure for 60 days after RST decline
5) Incidence of hospitalization and cardiac death due to heart failure in episodes with RST recovery after RST decline
6) Incidence of hospitalization and cardiac death due to heart failure in the group where RST did not decrease.
7) Incidence of RST recovery for one month after RST decline
Safety:
Medical device failure, diseases, etc.
HeartLab,Inc
Not applicable
Clinical Research Review Board, University of Toyama
