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
Qualifiers
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 design
Treatments tested in this trial
- Observational Assessment
Treatment groups
Locations
2Sponsors and collaborators
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