An observational study in Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD) and Hemodialysis Patients, sponsored by Stefan Lujinschi. Not yet recruiting at 2 sites in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Stefan Lujinschi · Observational
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.
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:
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.
1,092 studies on the registry are indexed under Hypertension, Pulmonary; 244 are open to participants now.
This study's planned enrollment of 30 is below the median of 110 across 381 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Stefan Lujinschi is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Adult patients with end-stage kidney disease (ESKD) receiving maintenance hemodialysis in two tertiary referral centers. Participants are consecutively enrolled and undergo structured volume assessment and optimization. The primary analysis includes patients who achieve predefined euvolemia criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with end-stage kidney disease on maintenance hemodialysis undergo a structured volume assessment (including clinical assessment, bioimpedance spectroscopy, inferior vena cava measurement, lung ultrasound and echocardiography) and, if necessary, a volume optimization phase. The primary study cohort includes patients who meet predefined euvolemia criteria. An exploratory subgroup includes patients with persistent hypervolemia, analyzed separately. Additional invasive evaluation, including right heart catheterization, may be performed only when clinically indicated and is not assigned as a study intervention.
Other: Observational Assessment
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.
Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients
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.
Time frame: 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 Phenotype Distribution
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.
Time frame: 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
Clinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension
Time frame: At baseline evaluation
Association Between Vascular Access and Pulmonary Hypertension
Relationship between vascular access type and pulmonary hypertension parameters.
Time frame: At baseline evaluation
Association Between Volume Status and Pulmonary Hypertension
Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.
Time frame: At baseline evaluation
Blood Pressure Variability and Pulmonary Hypertension
Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters.
Time frame: At baseline evaluation
Plan to share: Undecided
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