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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04061811
Acronym
SONGBIRD
Enrollment
153
Registered
2019-08-20
Start date
2018-08-01
Completion date
2019-02-28
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Heart Failure

Keywords

congestive heart failure (HF), biomarker, chronic kidney disease (CKD), hemodialysis (HD), peritoneal dialysis (PD), neprilysin (NEP), growth differentiation factor-15 (GDF15)

Brief summary

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.

Interventions

DIAGNOSTIC_TESTDiagnostic biomarker study

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.

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
F-CRIN
CollaboratorUNKNOWN
Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
HF diagnosisBaseline (at study entry (diagnostic biomarker study))Diagnosis of HF

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026