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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06942871
Enrollment
202
Registered
2025-04-24
Start date
2024-04-01
Completion date
2025-03-31
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Brief 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.

Interventions

DEVICERemote 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.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
all-cause mortality or clinical deterioration related to PHThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026