End Stage Kidney Disease (ESRD), Hemodialysis, Hemodialysis Patients, Pulmonary Hypertension (PH), Volume Assessment, Volume Overload
Conditions
Keywords
Pulmonary Hypertension, Hemodialysis, End-Stage Kidney Disease, Euvolemia, Volume Overload, Volume Status, Echocardiography, Bioimpedance Spectroscopy, Interdialytic Weight Gain, Vascular Access, Blood Pressure Variability, Lung Ultrasound
Brief summary
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.
Detailed description
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. The primary objective is to determine the prevalence of PH in euvolemic HD patients. Secondary objectives include characterization of PH phenotypes and identification of clinical, dialysis-related, and echocardiographic predictors. Right heart catheterization (RHC) is not mandated for all participants. In patients with echocardiographic findings suggestive of PHafter confirmation of euvolemia, RHC may be performed when clinically indicated and separately consented. When available, invasive hemodynamic data will be used to confirm PH and refine phenotype classification.
Interventions
Participants undergo structured clinical, echocardiographic, and volume status assessments, including bioimpedance spectroscopy, lung ultrasound and inferior vena cava evaluation. Volume optimization measures are applied as part of routine clinical care and are not assigned as experimental interventions. Right heart catheterization may be performed in selected patients when clinically indicated and after specific informed consent, and is not considered a study intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Distribution of pulmonary hypertension phenotypes based on echocardiographic assessment in the overall cohort, with definitive classification based on right heart catheterization in patients undergoing clinically indicated invasive evaluation. |
| Predictors of Pulmonary Hypertension | At baseline evaluation | Clinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension |
| Association Between Vascular Access and Pulmonary Hypertension | At baseline evaluation | Relationship between vascular access type and pulmonary hypertension parameters. |
| Association Between Volume Status and Pulmonary Hypertension | At baseline evaluation | Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension. |
| Blood Pressure Variability and Pulmonary Hypertension | At baseline evaluation | Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters. |
Countries
Romania
Contacts
Institute for Cardiovascular Diseases C.C. Iliescu
Fundeni Clinical Institute
Institute for Cardiovascular Diseases C.C. Iliescu