Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStefan Lujinschi

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 volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational Assessment

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Euvolemic Hemodialysis Cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Association Between Vascular Access and Pulmonary Hypertension

Relationship between vascular access type and pulmonary hypertension parameters.

Time frame
At baseline evaluation
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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