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NCT07676786
Euvolemia-Based Assessment of Pulmonary Hypertension in Stable Hemodialysis Patients
Conditions: Pulmonary Hypertension (PH), End Stage Kidney Disease (ESRD), Hemodialysis Patients, Volume Overload, Volume Assessment, Hemodialysis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: Stefan Lujinschi
Location: Institute for Cardiovascular Diseases C.C. Iliescu Bucharest
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07676786). StuddyBuddy aggregates publicly available trial information.