Skip to content

Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07676786
Acronym
EU-PHASE-HD
Enrollment
30
Registered
2026-06-30
Start date
2026-07-01
Completion date
2027-03-30
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Kidney Disease (ESRD), Hemodialysis, Hemodialysis Patients, Pulmonary Hypertension (PH), Volume Assessment, Volume Overload

Keywords

Pulmonary Hypertension, Hemodialysis, End-Stage Kidney Disease, Euvolemia, Volume Overload, Volume Status, Echocardiography, Bioimpedance Spectroscopy, Interdialytic Weight Gain, Vascular Access, Blood Pressure Variability, Lung Ultrasound

Brief 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.

Detailed description

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.

Interventions

OTHERObservational Assessment

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.

Sponsors

Stefan Lujinschi
Lead SponsorOTHER
Institutul Clinic Fundeni
CollaboratorOTHER
Carol Davila University of Medicine and Pharmacy
CollaboratorOTHER
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis PatientsAt 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 monthsPulmonary 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

MeasureTime frameDescription
Pulmonary Hypertension Phenotype DistributionAt 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 monthsDistribution 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.
Predictors of Pulmonary HypertensionAt baseline evaluationClinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension
Association Between Vascular Access and Pulmonary HypertensionAt baseline evaluationRelationship between vascular access type and pulmonary hypertension parameters.
Association Between Volume Status and Pulmonary HypertensionAt baseline evaluationAssociation between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.
Blood Pressure Variability and Pulmonary HypertensionAt baseline evaluationRelationship between intradialytic blood pressure variability and pulmonary hypertension parameters.

Countries

Romania

Contacts

CONTACTStefan N Lujinschi, MD, PhD candidate
stefanlujinschi@gmail.com+40728102643
PRINCIPAL_INVESTIGATORGeorgiana N Olaru, MD

Institute for Cardiovascular Diseases C.C. Iliescu

STUDY_CHAIRGener Ismail, Professor, MD, PhD

Fundeni Clinical Institute

STUDY_CHAIRIoan M Coman, Professor, MD, PhD

Institute for Cardiovascular Diseases C.C. Iliescu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026