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OpenTrials
Completed

NCT Number: NCT06942871

Non-Invasive Lung Water Monitoring in 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

180 Fenglin Road

Shanghai, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Dielectric Sensing

Device

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.

Primary outcomes

  1. all-cause mortality or clinical deterioration related to PH

    Time frame: The follow-up period is up to March 31, 2025.

    • all-cause death or lung transplantation; 2) rehospitalization due to PH-related heart failure; 3) worsening of WHO cardiac functional class.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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