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Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

NCT07676786 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2026-06-30

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Institutul Clinic Fundeni

    collaborator OTHER

  • Carol Davila University of Medicine and Pharmacy

    collaborator OTHER

  • Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

    collaborator OTHER

  • Stefan Lujinschi

    lead OTHER

Principal Investigators

  • Georgiana N Olaru, MD · Institute for Cardiovascular Diseases C.C. Iliescu

  • Gener Ismail, Professor, MD, PhD · Fundeni Clinical Institute

  • Ioan M Coman, Professor, MD, PhD · Institute for Cardiovascular Diseases C.C. Iliescu

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-02-28
Completion
2027-03-30

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676786 on ClinicalTrials.gov