Smartwatch-based Predictive and Interventional Research in Ambulatory Chronic Heart Failure Patients
SPIRA Trial
Misumi Yusuke
THE UNIVERSITY OF OSAKA HOSPITAL
2-15 Yamadaoka, Suita, Osaka
+81-6-6879-5111
prj-a-wave01_jrct@eps.co.jp
Misumi Yusuke
THE UNIVERSITY OF OSAKA HOSPITAL
2-15 Yamadaoka, Suita, Osaka
+81-6-6879-5111
prj-a-wave01_jrct@eps.co.jp
Pending
July. 02, 2026
132
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
prevention purpose
At Initial Registration
Subjects must meet all of the following criteria
1.Subjects aged 18 years or older at the time of obtaining informed consent, regardless of sex.
2.Subjects who have voluntarily provided written informed consent for participation in this clinical trial.
3.Subjects with chronic heart failure classified as Stage C or D according to the ACCF/AHA heart failure staging system.
4.Subjects with NT-proBNP at least 900 pg/mL at screening.
5.Subjects classified as New York Heart Association (NYHA) Class II or III.
6.Subjects who are either outpatients, or currently hospitalized due to heart disease but are considered by the investigator or sub-investigator to be capable of outpatient visits after discharge.
7.Subjects who are able to understand Japanese used in the investigational device.
8.Subjects who are ambulatory without assistance (use of assistive devices such as a cane is permitted).
At Secondary Registration (Intervention group only)
Subjects must meet all of the following criteria
1.Subjects who have completed the training (1 within 7 days)
and have been assessed by trial staff using the device training checklist to be
able to use the investigational device without problems.
( After initial registration, a training period of up to 7 days shall be provided when the subject takes the investigational device home and initiates use.)
2.Subjects for whom measured data have been confirmed for two consecutive days, satisfying all of the following
1. Data on symptoms, body weight, and heart sounds have been recorded for two consecutive days
2. Activity data of at least 24.5 METsh have been recorded
3. Heart sounds analyzable by the investigational device have been successfully obtained
At Initial Registration
Subjects who meet any of the following criteria shall be excluded
1.Subjects classified as New York Heart Association (NYHA) Class IV.
2.Subjects in whom auscultation is difficult due to implanted devices (e.g., port, pacemaker, breast implant) or conditions such as ulcers in the area from the sternum to the left nipple.
3.Subjects using implantable devices with heart failure monitoring functions (e.g., OptiVol TM).
4.Subjects who have undergone mechanical heart valve replacement.
5.Subjects who are unable to continuously wear the investigational device on the wrist during daytime.
6.Subjects diagnosed with dementia.
7.Subjects for whom the physician determines that heart failure is predominantly right-sided.
8.Subjects with adult congenital heart disease (excluding those after ASD or VSD closure).
9.Subjects in whom adequate heart sounds cannot be confirmed by auscultation by a physician.
10.Subjects in whom a third heart sound (S3) is detectable at screening.
11.Subjects with serum creatinine at least 3.0 mg/dL.
12.Subjects receiving dialysis for renal failure.
13.Subjects who are currently participating in another interventional study (including clinical trials) within 3 months prior to enrollment.
14.Subjects with malignant tumors (except for those with no recurrence for at least 5 years).
15.Subjects with liver cirrhosis classified as Child Pugh Grade B or higher.
16.Subjects with progressive diseases expected to limit survival to less than 1 year (e.g., liver failure).
17.Pregnant or possibly pregnant women, or breastfeeding women.
18.Subjects deemed by the investigator or sub investigator to be inappropriate for participation in this clinical trial.
At Secondary Registration (Intervention group only)
Subjects who meet any of the following criteria shall be excluded
1.Subjects who are hospitalized between initial and secondary registration
(However, if the subject recovers after hospitalization, re-screening may be performed and participation is allowed with assignment of a new subject identification number).
2.Subjects who are found to meet any of the exclusion criteria for initial registration after enrollment.
3.Subjects whose loaned smartphone indicates out of service area at home.
4.Subjects deemed by the investigator or sub-investigator to be inappropriate for participation in this clinical trial.
18age old over
No limit
Both
Stage C/D CHF with structural heart disease and prior HF hospitalization.
In the intervention group, participants will wear a multimodal sensor at home. Heart sounds (S3) will be recorded twice daily, and physical activity (acceleration) will be automatically measured hourly. At each heart sound recording, participants will enter subjective symptoms via a patient application.
In the control group, the interval of outpatient visits will be determined by the investigator based on routine clinical practice, and standard disease management will be provided in accordance with the 2025 Heart Failure Guidelines (JCS2025/JHFS2025).
In the intervention group, in addition to standard management, collected data will be analyzed on a central server. If signs of heart failure worsening are detected, notifications will be sent to both the participant and the investigator, and an unscheduled visit will be instructed as needed. At both scheduled and unscheduled visits, NT-proBNP will be measured, and heart failure exacerbation will be assessed in combination with clinical evaluation.
Time to the first heart failure related event from the start of observation to the end of observation
1.Incidence of heart failure related events from observation start to observation end
2.Sensitivity, specificity, positive predictive value, and negative predictive value of device-based assessments compared with laboratory-based assessments for NT-proBNP elevation (at least 30% increase from baseline)
3.Percentage change in NT-proBNP at unscheduled visits
4.Number of unscheduled visits related to worsening heart failure
5.Duration of treatment during hospitalization (number of days from admission [defined as Day 1] until NT-proBNP decreases to <10% above baseline)
6.Framingham congestive heart failure criteria score (number of positive criteria)
7.Estimated pulmonary artery pressure by transthoracic echocardiography at scheduled Week 52 visits and at unscheduled visits
8.Estimated pulmonary artery pressure by transthoracic echocardiography at hospitalization
9.KCCQ-Overall Summary (KCCQ-OS) score at scheduled visits
10.KCCQ-Overall Summary (KCCQ-OS) score at discontinuation and hospitalization
11.Number of defibrillator activations in implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D), excluding ATP
12Same-day visit rate following visit recommendations
13.Dropout rate of device use
A-wave, Inc.
Not applicable
Institutional Review Board of Osaka University Hospital
