Clinical Trial

Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

Study acronym: EU-PHASE-HD
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07676786
Lead Sponsor Stefan Lujinschi
Collaborators: Institutul Clinic Fundeni, Carol Davila University of Medicine and Pharmacy, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Conditions Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload, Volume Assessment, Hemodialysis
Enrollment 30 participants
Start Date 2026-07-01
Primary Completion 2027-02-28 (estimated)
Study Completion 2027-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30