About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational Assessment
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Predictors of Pulmonary Hypertension
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
Relationship between vascular access type and pulmonary hypertension parameters.
Association Between Volume Status and Pulmonary Hypertension
Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.
Sponsors and contacts
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Stefan Lujinschi
Lead sponsor
Institutul Clinic Fundeni
Sponsor institution
Institutul Clinic Fundeni
Collaborator
Carol Davila University of Medicine and Pharmacy
Collaborator
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Collaborator
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