Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: ReDS-GuidedOther: Usual care
- Registration Number
- NCT06102031
- Lead Sponsor
- Shanghai Zhongshan Hospital
- Brief Summary
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.
- Detailed Description
The main purpose of this study is to explore and validate the effectiveness by using ReDS™ 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
1. Stage 1 is the observation stage for selected heart failure patients during the hospitalization period (from enrollment to discharge). During this stage, patients complete screening, enrollment, and randomization within 72 hours after admission, and are randomly assigned to the experimental group or control group in a 1:1 ratio. All patients receive ReDS™ measurement on the day after randomization, but without using measurement data to intervene the treatment during hospitalization. The randomization of patients and the measurement data remained blind to the treatment clinicians.
2. Stage 2 is the intervention stage, which lasts for 12 months. Firstly, two groups of patients receive ReDS™ measurement on the day of planned discharge. For the control group, this measurement data will still not used as a reference for discharge decision, and remains blind to clinicians; For the experimental group, treatment clinicians will give interventional therapy based on the ReDS™ results.
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Arm-Treatment Group ReDS-Guided Management of subjects based on lung fluid content derived from the ReDS™ system. All subjects will receive ReDS™ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDS™ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDS™ test wil be performed every 15 days. Then ReDS™ 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. Randomized Arm-Control Group Usual care Management of subjects based on standard of care(signs, symptoms, weight, biomarkers, etc.) without lung fluid content information. All subjects will receive ReDS™ test during hospitalization, at discharge, several home visits and 3 times outpatient follow-up. For home visits frequency, ReDS™ tests will be performed every 7 days within 1 month of discharge; at the 2nd to 3rd month, ReDS™ test wil be performed every 15 days. Then ReDS™ 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.
- Primary Outcome Measures
Name Time Method The number of cardiovascular deaths 12 months post-discharge. The number of recurrent heart failure readmissions 12 months post-discharge. 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 ReDS™ home visit , it should not be recorded as an event of heart failure (as this is part of the planned follow-up).
The change of KCCQ score 12 months post-discharge.
- Secondary Outcome Measures
Name Time Method Cardiovascular readmissions 12 months post-discharge. The number of recurrent cardiovascular readmissions.
First time heart failure readmission 12 months post-discharge. The time from discharge to first heart failure readmission.
Change of NT-proBNP 12 months post-discharge. The change of NT-proBNP measurements.
All-cause readmissions 12 months post-discharge. The number of recurrent all-cause readmissions.
Cardiovascular mortality 12 months post-discharge. The number of cardiovascular deaths.
All-cause mortality 12 months post-discharge. The number of all-cause deaths.
all-cause mortality 12 months post-discharge. The number of all-cause deaths