Pulmonary Hypertension (PH)EU-PHASE-HDNCT07676786
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
An observational study of Pulmonary Hypertension (PH) and End Stage Kidney Disease (ESRD), run by Stefan Lujinschi at 2 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients
- What is being tested?
- Observational Assessment
- How many people
- 30 participants
- Where
- 2 sitesRomania
- Study dates
- 1 Jul 2026to 30 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites
Institute for Cardiovascular Diseases C.C. Iliescu
Bucharest, 022322
Georgiana Olaru, MD, +40767805197, dr.georgianaolaru@yahoo.com
Georgiana Olaru, MD
Fundeni Clinical Institute
Bucharest, 022328
Stefan N Lujinschi, MD, PhD candidate, +40728102643, stefanlujinschi@gmail.com
Stefan N Lujinschi, MD, PhD candidate
About this study
Official title: Prospective Observational Study on Predictors and Types of Pulmonary Hypertension in Euvolemic Patients With End-Stage Kidney Disease on Maintenance Hemodialysis
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.
Read more
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.
Read the 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.
- Conditions
- Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload, Volume Assessment, Hemodialysis
- Being tested
- Observational Assessment
- 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
- Medical subject headings
- Hypertension, Pulmonary, Kidney Failure, Chronic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Clinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension
Measured: At baseline evaluation
Association Between Vascular Access and Pulmonary Hypertension
Relationship between vascular access type and pulmonary hypertension parameters.
Measured: At baseline evaluation
Association Between Volume Status and Pulmonary Hypertension
Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.
Measured: At baseline evaluation
Blood Pressure Variability and Pulmonary Hypertension
Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters.
Measured: At baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension (PH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefan Lujinschi
- Sponsor type
- University, hospital or other
- Collaborators
- Institutul Clinic Fundeni, Carol Davila University of Medicine and Pharmacy, Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
- Responsible party
- Sponsor-investigator, Stefan Lujinschi, Institutul Clinic Fundeni
- Investigators
- Georgiana N Olaru, MD, Principal investigator, Institute for Cardiovascular Diseases C.C. IliescuGener Ismail, Professor, MD, PhD, Study chair, Fundeni Clinical InstituteIoan M Coman, Professor, MD, PhD, Study chair, Institute for Cardiovascular Diseases C.C. Iliescu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676786
- Sponsor's protocol ID
- 12798
- Other IDs
- 12798, EU-PHASE-HD-01
- Acronym
- EU-PHASE-HD
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided