Non-Invasive Lung Water Monitoring Guided by Remote Dielectric Sensing Technology in the Management of Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- all-cause mortality or clinical deterioration related to PH
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
all-cause mortality or clinical deterioration related to PH
时间窗: 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.
次要结局
未报告次要终点