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

24. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pulmonary Hypertension Phenotype Distribution
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At baseline evaluation
Relationship between vascular access type and pulmonary hypertension parameters.
At baseline evaluation
Association Between Volume Status and Pulmonary Hypertension
Zeitfenster: 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
Zeitfenster: At baseline evaluation
Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters.
At baseline evaluation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stefan Lujinschi

Mitarbeiter

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

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

28. Februar 2027

Studienabschluss (Geschätzt)

30. März 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juni 2026

Zuerst gepostet (Tatsächlich)

30. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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