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This clinical study is a multicenter, randomized, controlled clinical study to evaluate the effectiveness of using the noninvasive lung fluid monitoring system based on remote dielectric sensing in guiding the treatment of heart failure.
The main purpose of this study is to explore and validate the effectiveness by using ReDSâ„¢ to guide the treatment of heart failure patients during hospitalization and after discharge based on current routine treatment.
The study is divided into two stages
Approximately 1000 patients will be randomly assigned to the experimental group or control group in a 1:1 ratio, with 500 patients in each group.
Primary/secondary endpoint analysis: will be based on all randomized patients (i.e. ITT population). The Kaplan Meier method was used to estimate the median TTF for each study group. Using the Cox regression model, calculate the regression coefficients or HR values, and their 95% CI. Using forest maps (including HR estimates) to evaluate the homogeneity of intervention effects in important subgroups. The predetermined subgroup analysis will provide additional detailed information in SAP. The hypothesis of primary and secondary endpoints will be formally tested using SAS and Stata statistical software at a unilateral significance level of 0.025.
Safety analysis: Randomized safety analysis based on the safety analysis population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Arm-Treatment Group | Experimental | Management of subjects based on lung fluid content derived from the ReDSâ„¢ system. All subjects will receive ReDSâ„¢ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDSâ„¢ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDSâ„¢ test wil be performed every 15 days. Then ReDSâ„¢ test will be performed every 30 days from 4th to 12th months. Patients will be followed up in outpatient at 3 months, 6 months, and 12 months after discharge. |
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| Randomized Arm-Control Group | Sham Comparator | Management of subjects based on standard of care(signs, symptoms, weight, biomarkers, etc.) without lung fluid content information. All subjects will receive ReDSâ„¢ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDSâ„¢ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDSâ„¢ test wil be performed every 15 days. Then ReDSâ„¢ test will be performed every 30 days from 4th to 12th months. Patients will be followed up in outpatient at 3 months, 6 months, and 12 months after discharge. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReDS-Guided | Device | ReDS™ measurements will be shared with the treating clinicians to guide diuretic treatment when discharge, home visit and outpatient follow-up, but blinded to the subjects. At discharge:①If the ReDS™ reading <36%, discharge as planned; ②ReDS™ reading ≥36%, increase the oral diuretic dose, discharge as planned. When home visit and outpatient follow-up: ①If the ReDS™ reading <20%, hold diuretics; ② If the ReDS™ reading was between 21-35%, maintain current diuretic dose and optimize GDMT. If the ReDS™ change ≥ 6% from the previous one, increase diuretic dose and optimize the GDMT; ③ If the ReDS™ reading was between 36-45%, increase diuretics and optimize the GDMT, then repeat ReDS™ test after 1 week(home visit); ④ If the ReDS™ reading was above 46%, consider intravenous diuretic therapy, and repeat ReDS™ test after 1 week(home visit) or hospitalization. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of cardiovascular deaths | 12 months post-discharge. | |
| The number of recurrent heart failure readmissions | A heart failure readmission is defined as a hospitalization due to worsening heart failure or an emergency department visit requiring intravenous diuretic treatment. If a patient in the ReDS-Guided group is suggested to receive intravenous diuretic based on the ReDSâ„¢ home visit , it should not be recorded as an event of heart failure (as this is part of the planned follow-up). | 12 months post-discharge. |
| The change of KCCQ score | 12 months post-discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular readmissions | The number of recurrent cardiovascular readmissions. | 12 months post-discharge. |
| all-cause mortality | The number of all-cause deaths |
| Measure | Description | Time Frame |
|---|---|---|
| Total medical costs in the short term (during clinical trials) | Health economics evaluation endpoint | 12 months post-discharge. |
| Short term (clinical trial period) total QALY | Health economics evaluation endpoint |
Inclusion criteria:
1) Difficulty breathing during screening due to rest or activity; 2) Chest X-ray or chest CT shows clinical manifestations such as pulmonary congestion, pulmonary edema, and pleural effusion; 3) After the onset of this disease and before screening, any test meets the following criteria: BNP ≥ 400 pg/mL or NT proBNP ≥ 1600 pg/mL in patients with sinus rhythm, BNP ≥ 600 pg/mL or NT proBNP ≥ 2400 pg/mL in patients with atrial fibrillation; 4) Intravenous diuretic treatment is required.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Cui | Contact | 13681959319 | cui.xiaotong@zs-hospital.sh.cn |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Usual care | Other | ReDS measurements will not be shared with the treating clinicians and the subjects, diuretic treatment will only be guided using standard clinical care. |
|
| 12 months post-discharge. |
| First time heart failure readmission | The time from discharge to first heart failure readmission. | 12 months post-discharge. |
| All-cause readmissions | The number of recurrent all-cause readmissions. | 12 months post-discharge. |
| Cardiovascular mortality | The number of cardiovascular deaths. | 12 months post-discharge. |
| All-cause mortality | The number of all-cause deaths. | 12 months post-discharge. |
| Change of NT-proBNP | The change of NT-proBNP measurements. | 12 months post-discharge. |
| 12 months post-discharge. |
| Incremental Cost Effect Ratio (ICER) | Health economics evaluation endpoint | 12 months post-discharge. |