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NCT Number: NCT07676786

Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

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.

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Key information

About this study

Pulmonary hypertension (PH), defined as mean pulmonary arterial pressure (mPAP) >20 mmHg, is increasingly recognized in patients with chronic kidney disease and is particularly prevalent in those with ESKD on maintenance HD.

Despite its prognostic importance, PH remains under-recognized and insufficiently characterized in HD patients. A major limitation of prior studies is the lack of standardized assessment of volume status, which significantly influences pulmonary pressures.

This prospective, multicenter cohort study aims to address this gap by evaluating PH after rigorous volume optimization. The study includes:

  • A pretrial volume assessment phase (3 consecutive HD sessions)
  • A structured volume correction phase (if needed)
  • A main study cohort including only euvolemic patients
  • An exploratory subgroup of patients with persistent hypervolemia

Euvolemia is defined using a multimodal approach including clinical examination, bioimpedance spectroscopy, inferior vena cava (IVC) diameter, interdialytic weight gain, blood pressure stability, and lung ultrasound criteria.

The primary objective is to determine the prevalence of PH in euvolemic HD patients. Secondary objectives include characterization of PH phenotypes and identification of clinical, dialysis-related, and echocardiographic predictors.

Right heart catheterization (RHC) is not mandated for all participants. In patients with echocardiographic findings suggestive of PHafter confirmation of euvolemia, RHC may be performed when clinically indicated and separately consented. When available, invasive hemodynamic data will be used to confirm PH and refine phenotype classification.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Provision of written informed consent

Exclusion criteria

  • 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.
  • Acute infection or inflammatory condition at the time of enrollment.
  • Inadequate echocardiographic window preventing reliable assessment

Treatment and study plan

Observational Assessment

Other

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.

Primary outcomes

  1. Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients

    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

    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

  1. Pulmonary Hypertension Phenotype Distribution

    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

    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.

  2. Predictors of Pulmonary Hypertension

    Time frame: At baseline evaluation

    Clinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension

  3. Association Between Vascular Access and Pulmonary Hypertension

    Time frame: At baseline evaluation

    Relationship between vascular access type and pulmonary hypertension parameters.

  4. Association Between Volume Status and Pulmonary Hypertension

    Time frame: At baseline evaluation

    Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.

  5. Blood Pressure Variability and Pulmonary Hypertension

    Time frame: At baseline evaluation

    Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan N Lujinschi, MD, PhD candidate

CONTACT

[email protected]

+40728102643

Sponsors and collaborators

Lead sponsor

Stefan Lujinschi

Other

Collaborators

  • Carol Davila University of Medicine and Pharmacy
  • Institutul Clinic Fundeni
  • Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

Registry information

Official study title

Prospective Observational Study on Predictors and Types of Pulmonary Hypertension in Euvolemic Patients With End-Stage Kidney Disease on Maintenance Hemodialysis

Acronym: EU-PHASE-HD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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