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Clinical Study on the Noninvasive Lung Fluid Monitoring System in Guiding the Treatment of Heart Failure
Sponsor: Shanghai Zhongshan Hospital
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.
Official title: 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
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2023-11
Completion Date
2026-12
Last Updated
2023-10-26
Healthy Volunteers
No
Conditions
Interventions
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.
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.