NCT06942871

Non-Invasive Lung Water Monitoring in Pulmonary Hypertension

Non-Invasive Lung Water Monitoring Guided by Remote Dielectric Sensing Technology in the Management of Patients With Pulmonary Hypertension

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 202 (actual)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. The measurement of Remote Dielectric Sensing (ReDS) values was performed by ReDS™ Pro. Data were collected using the electronic medical record system of our hospital. Participants were followed up within 6 months after discharge. The primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension.

Detailed description

The investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. The measurement of Remote Dielectric Sensing (ReDS) values was performed by ReDS™ Pro. Data were collected using the electronic medical record system of our hospital. Participants were followed up within 6 months after discharge. The primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension. Data were collected using the electronic medical record system of our hospital, including demographics, clinical diagnoses, past medical history, ancillary examinations and laboratory test, surgical procedures, and medication use. Treatment and management of participants were in accordance with guideline recommendations. Participants were followed up by telephone or outpatient visits within 6 months after discharge.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	Remote Dielectric Sensing	The lung fluid monitor Remote Dielectric Sensing (ReDS™) is the world's first non-invasive device for heart failure monitoring and management. It directly reflects lung fluid content by measuring changes in thoracic dielectric constants, with a detection range of 15% \~ 60%. The device can sensitively identify pathological states ranging from mild compensation to severe pulmonary edema. ReDS™ technology cannot directly measure pulmonary artery pressure, but changes in lung fluid content may indirectly reflect disease progression in certain types of pulmonary hypertension.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-05
• Completion: 2025-03-31
• First posted: 2025-04-24
• Last updated: 2025-04-29

Locations

1 site across 1 country: China