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NOT YET RECRUITING
NCT06102031
NA

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

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.