Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

NCT07676786 | Not Yet Recruiting

• 2 other identifiers: 12798EU-PHASE-HD-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

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

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

Outcome Measures

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.

  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 (5)

• Pulmonary Hypertension Phenotype Distribution

  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

• Predictors of Pulmonary Hypertension

  At baseline evaluation

• Association Between Vascular Access and Pulmonary Hypertension

  At baseline evaluation

• Association Between Volume Status and Pulmonary Hypertension

  At baseline evaluation

• Blood Pressure Variability and Pulmonary Hypertension

  At baseline evaluation

Study Arms (1)

Euvolemic Hemodialysis Cohort

Participants with end-stage kidney disease on maintenance hemodialysis undergo a structured volume assessment (including clinical assessment, bioimpedance spectroscopy, inferior vena cava measurement, lung ultrasound and echocardiography) and, if necessary, a volume optimization phase. The primary study cohort includes patients who meet predefined euvolemia criteria. An exploratory subgroup includes patients with persistent hypervolemia, analyzed separately. Additional invasive evaluation, including right heart catheterization, may be performed only when clinically indicated and is not assigned as a study intervention.

Other: Observational Assessment

Interventions

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.

Euvolemic Hemodialysis Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Institute for Cardiovascular Diseases C.C. Iliescu

Bucharest, 022322, Romania

Location

Fundeni Clinical Institute

Bucharest, 022328, Romania

Location

MeSH Terms

Conditions

Hypertension, Pulmonary; Kidney Failure, Chronic; Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Georgiana N Olaru, MD

  Institute for Cardiovascular Diseases C.C. Iliescu

  PRINCIPAL INVESTIGATOR

• Gener Ismail, Professor, MD, PhD

  Fundeni Clinical Institute

  STUDY CHAIR

• Ioan M Coman, Professor, MD, PhD

  Institute for Cardiovascular Diseases C.C. Iliescu

  STUDY CHAIR

Central Study Contacts

Stefan N Lujinschi, MD, PhD candidate

CONTACT

+40728102643; stefanlujinschi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD candidate

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

RO (2)