Non-Invasive Lung Water Monitoring in Pulmonary Hypertension

April 25, 2025 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Inpatients and outpatients with PH who were admitted to the Department of Cardiology at Zhongshan Hospital, Fudan University, between April 2024 and March 2025 were prospectively enrolled in this study.

Description

Inclusion Criteria:

  • Age ≥18 and ≤85 years, with no gender restriction;
  • Hemodynamic confirmation of PH via right heart catheterization (RHC) (mean pulmonary arterial pressure [mPAP] > 20 mmHg).

Exclusion Criteria:

  • Thoracic deformities or injuries precluding proper device fit (e.g., severe scoliosis, flail chest);
  • Inability to use the ReDS™ Pro non-invasive lung fluid monitor due to physical characteristics (height <155 cm or >190 cm; body mass index [BMI] <22 kg/m² or >39 kg/m²);
  • Prior implantation of a left ventricular assist device or cardiac transplantation;
  • Congenital cardiac anomalies or intrathoracic masses affecting right lung anatomy;
  • Hemodynamic profiles inconsistent with PH.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lung fluid
The measurement of ReDS values was performed with the patient in a seated position and under normal breathing conditions. It was conducted on the morning of the second day following admission or at the end of an outpatient visit. The device's sensors or vest were properly placed on the patient's chest to ensure good contact between the sensors and the skin. Upon initiating the measurement program, the device emitted low-power electromagnetic signals that passed through the thorax and lungs. It measured the dielectric constant (impedance) of the lungs and calculated the percentage of lung fluid. The manufacturer-recommended normal range is between 20% and 35%. The entire measurement process took approximately 45 seconds.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality or clinical deterioration related to PH
Time Frame: The follow-up period is up to March 31, 2025.
1) all-cause death or lung transplantation; 2) rehospitalization due to PH-related heart failure; 3) worsening of WHO cardiac functional class.
The follow-up period is up to March 31, 2025.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Dandan CHEN, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

March 31, 2025

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDS in PAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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