Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients

Study Overview
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Brief Summary
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Objectives: The aim of this study is to determine whether growth differentiation factor-15 (GDF15) and circulating neprilysin (cNEP) improve the diagnosis of congestive heart failure (HF) in patients on dialysis. Background: Dialysis patients are at increased risk of HF. However, diagnostic utility of NT-proBNP as a biomarker is decreased in patients on dialysis. GDF15 and cNEP are biomarkers of distinct mechanisms that may contribute to HF pathophysiology in such cohorts. Methods: We compare circulating concentrations of NT-proBNP, GDF15, and cNEP along with NEP activity in patients on chronic dialysis without and with HF, as diagnosed by clinical parameters and post-dialysis echocardiography. We use correlation, linear and logistic regression as well as receiver operating characteristic (ROC) analyses.

Official Title
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Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients

Conditions
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Heart Failure, End Stage Renal Disease

Intervention / Treatment
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* Diagnostic Test: Diagnostic biomarker study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months Exclusion Criteria: previous switch of the type of renal replacement therapy from HD to PD or vice versa age <18 years pregnancy plasma exchange or apheresis in the past 6 months unipolar pacemaker history of whole extremity amputation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HF (heart failure)<br>Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction. | Diagnostic Test: Diagnostic biomarker study<br>* Comparing circulating concentrations of NT-proBNP, GDF15, and neprilysin (NEP) along with NEP activity in patients with and without HF, as diagnosed by clinical parameters and post-dialysis echocardiography.<br>|
| Control<br>Patients with end stage renal disease requiring dialysis without HF. | Diagnostic Test: Diagnostic biomarker study<br>* Comparing circulating concentrations of NT-proBNP, GDF15, and neprilysin (NEP) along with NEP activity in patients with and without HF, as diagnosed by clinical parameters and post-dialysis echocardiography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF diagnosis | Diagnosis of HF | Baseline (at study entry (diagnostic biomarker study)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congestive heart failure (HF), biomarker, chronic kidney disease (CKD), hemodialysis (HD), peritoneal dialysis (PD), neprilysin (NEP), growth differentiation factor-15 (GDF15)