Prospective Observational Study on Predictors and Types of Pulmonary Hypertension in Euvolemic Patients With End-Stage Kidney Disease on Maintenance Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients
研究概览
简要总结
Pulmonary hypertension (PH) is a frequent and clinically significant complication in patients with end-stage kidney disease (ESKD) undergoing maintenance hemodialysis (HD). However, PH assessment in this population is often confounded by volume overload, leading to potential overestimation and misclassification.
This prospective, multicenter observational study aims to evaluate the prevalence, phenotype, and predictors of PH in HD patients under standardized euvolemic conditions. A structured pretrial phase including volume assessment and correction will be performed prior to echocardiographic evaluation, which will be conducted after confirmation of euvolemia, post-hemodialysis or on the following day.
In participants with echocardiographic findings suggestive of PH, right heart catheterization may be performed when clinically indicated and after obtaining specific informed consent.
The study integrates clinical, biological, dialysis-related, and echocardiographic data to provide a comprehensive characterization of PH in a well-defined ESKD population.
详细描述
Pulmonary hypertension (PH), defined as mean pulmonary arterial pressure (mPAP) >20 mmHg, is increasingly recognized in patients with chronic kidney disease and is particularly prevalent in those with ESKD on maintenance HD.
Despite its prognostic importance, PH remains under-recognized and insufficiently characterized in HD patients. A major limitation of prior studies is the lack of standardized assessment of volume status, which significantly influences pulmonary pressures.
This prospective, multicenter cohort study aims to address this gap by evaluating PH after rigorous volume optimization. The study includes:
- A pretrial volume assessment phase (3 consecutive HD sessions)
- A structured volume correction phase (if needed)
- A main study cohort including only euvolemic patients
- An exploratory subgroup of patients with persistent hypervolemia
Euvolemia is defined using a multimodal approach including clinical examination, bioimpedance spectroscopy, inferior vena cava (IVC) diameter, interdialytic weight gain, blood pressure stability, and lung ultrasound criteria.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •End-stage kidney disease on maintenance HD for ≥ 3 months.
- •Stable clinical condition (no hospitalization in last 30 days).
- •Able and willing to comply with study protocol.
- •Provision of written informed consent
排除标准
- •Moderate/severe left-sided valvular disease.
- •Active pulmonary or cardiac decompensation.
- •Persistent hypervolemia after completion of the volume assessment and correction phase
- •Inability to undergo echocardiography or bioimpedance assessment.
- •Acute infection or inflammatory condition at the time of enrollment.
- •Inadequate echocardiographic window preventing reliable assessment
结局指标
主要结局
Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients
时间窗: At baseline echocardiographic evaluation after confirmation of euvolemia (within 1 week, post-hemodialysis or next day); in participants undergoing clinically indicated right heart catheterization, assessment may occur within 3 months
Pulmonary hypertension will be identified based on echocardiographic criteria (systolic pulmonary arterial pressure \[sPAP\] ≥40 mmHg) after confirmation of euvolemia. In participants undergoing clinically indicated right heart catheterization, invasive hemodynamic data (mean pulmonary arterial pressure \[mPAP\] ≥20 mmHg) will be used for confirmation of pulmonary hypertension.
次要结局
- Pulmonary Hypertension Phenotype Distribution(At baseline echocardiography after euvolemia (within 1 week, post-hemodialysis or next day); in participants with clinically indicated right heart catheterization, assessment may occur within 3 months)
- Predictors of Pulmonary Hypertension(At baseline evaluation)
- Association Between Vascular Access and Pulmonary Hypertension(At baseline evaluation)
- Association Between Volume Status and Pulmonary Hypertension(At baseline evaluation)
- Blood Pressure Variability and Pulmonary Hypertension(At baseline evaluation)
研究者
Stefan Lujinschi
MD, PhD candidate
Institutul Clinic Fundeni