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| ID | Type | Description | Link |
|---|---|---|---|
| 12798 | Other Identifier | Fundeni Clinical Institute - Ethics Committee | |
| EU-PHASE-HD-01 | Other Identifier | Fundeni Clinical Institute - Adult Nephrology Department |
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| Name | Class |
|---|---|
| Institutul Clinic Fundeni | OTHER |
| Carol Davila University of Medicine and Pharmacy | OTHER |
| Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Assessment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Pulmonary Hypertension in Euvolemic Hemodialysis Patients | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Hypertension Phenotype Distribution | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan N Lujinschi, MD, PhD candidate | Contact | +40728102643 | stefanlujinschi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Georgiana N Olaru, MD | Institute for Cardiovascular Diseases C.C. Iliescu | Principal Investigator |
| Gener Ismail, Professor, MD, PhD | Fundeni Clinical Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Cardiovascular Diseases C.C. Iliescu | Bucharest | 022322 | Romania |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D007676 | Kidney Failure, Chronic |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| Predictors of Pulmonary Hypertension | 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 | Relationship between vascular access type and pulmonary hypertension parameters. | At baseline evaluation |
| Association Between Volume Status and Pulmonary Hypertension | Association between bioimpedance, inferior vena cava diameter, interdialytic weight gain, and pulmonary hypertension. | At baseline evaluation |
| Blood Pressure Variability and Pulmonary Hypertension | Relationship between intradialytic blood pressure variability and pulmonary hypertension parameters. | At baseline evaluation |
| Ioan M Coman, Professor, MD, PhD |
| Institute for Cardiovascular Diseases C.C. Iliescu |
| Study Chair |
| Fundeni Clinical Institute | Bucharest | 022328 | Romania |
|
| D002318 |
| Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |