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NCT07676786

Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients

Sponsor: Stefan Lujinschi

View on ClinicalTrials.gov

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.

Official title: Prospective Observational Study on Predictors and Types of Pulmonary Hypertension in Euvolemic Patients With End-Stage Kidney Disease on Maintenance Hemodialysis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-07-01

Completion Date

2027-03-30

Last Updated

2026-06-30

Healthy Volunteers

No

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.

Locations (2)

Institute for Cardiovascular Diseases C.C. Iliescu

Bucharest, Romania

Fundeni Clinical Institute

Bucharest, Romania