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

30 Participants
are divided into 1 treatment group

Locations

2
Fundeni Clinical Institute022328, Bucharest Romania
Institute for Cardiovascular Diseases C.C. Iliescu022322, Bucharest Romania

Sponsors 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