NCT06102031

Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart Failure

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	ReDS-Guided	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:① If 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: ① If 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.
OTHER	Usual care	ReDS measurements will not be shared with the treating clinicians and the subjects, diuretic treatment will only be guided using standard clinical care.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-11-01
• Completion: 2026-12-01
• First posted: 2023-10-26
• Last updated: 2023-10-26