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Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients (EU-PHASE-HD)

24. juni 2026 opdateret af: Stefan Lujinschi

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.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Rumænien
      • Bucharest, Rumænien, 022328
        • Fundeni Clinical Institute
        • Kontakt:
        • Ledende efterforsker:
          • Stefan N Lujinschi, MD, PhD candidate
      • Bucharest, Rumænien, 022322
        • Institute for Cardiovascular Diseases C.C. Iliescu
        • Kontakt:
        • Ledende efterforsker:
          • Georgiana Olaru, MD
        • Underforsker:
          • Lucian M Predescu, Assist. Prof., MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

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  • Voksen
  • Ældre voksen

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Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Observational 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients
Tidsramme: 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.
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pulmonary Hypertension Phenotype Distribution
Tidsramme: 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.
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
Tidsramme: At baseline evaluation
Clinical, laboratory, dialysis-related, vascular access-related, and volume-related variables associated with the presence of pulmonary hypertension
At baseline evaluation
Association Between Vascular Access and Pulmonary Hypertension
Tidsramme: At baseline evaluation
Relationship between vascular access type and pulmonary hypertension parameters.
At baseline evaluation
Association Between Volume Status and Pulmonary Hypertension
Tidsramme: At baseline evaluation
Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension.
At baseline evaluation
Blood Pressure Variability and Pulmonary Hypertension
Tidsramme: At baseline evaluation
Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters.
At baseline evaluation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stefan Lujinschi

Samarbejdspartnere

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

Efterforskere

  • Studiestol: Gener Ismail, Professor, MD, PhD, Fundeni Clinical Institute
  • Ledende efterforsker: Georgiana N Olaru, MD, Institute for Cardiovascular Diseases C.C. Iliescu
  • Studiestol: Ioan M Coman, Professor, MD, PhD, Institute for Cardiovascular Diseases C.C. Iliescu

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

28. februar 2027

Studieafslutning (Anslået)

30. marts 2027

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12798 (Anden identifikator: Fundeni Clinical Institute - Ethics Committee)
  • EU-PHASE-HD-01 (Anden identifikator: Fundeni Clinical Institute - Adult Nephrology Department)

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