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

H

Hannover Medical School (MHH)

Status

Completed

Conditions

End Stage Renal Disease
Heart Failure

Treatments

Diagnostic Test: Diagnostic biomarker study

Study type

Observational

Funder types

Other

Identifiers

NCT04061811
7952_BO_S_2018
KlinStrucMed program (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

153 participants in 2 patient groups

HF (heart failure)
Description:
Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction.
Treatment:
Diagnostic Test: Diagnostic biomarker study
Control
Description:
Patients with end stage renal disease requiring dialysis without HF.
Treatment:
Diagnostic Test: Diagnostic biomarker study

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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