CClinicalTrials.gg
CompletedNCT04061811SONGBIRDUpdated Aug 20, 2019

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

An observational study in Heart Failure and End Stage Renal Disease, sponsored by Hannover Medical School. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-20.

Sponsored by Hannover Medical School · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
153
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure
  • End Stage Renal Disease

Keywords

  • congestive heart failure (HF)
  • biomarker
  • chronic kidney disease (CKD)
  • hemodialysis (HD)
  • peritoneal dialysis (PD)
  • neprilysin (NEP)
  • growth differentiation factor-15 (GDF15)
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 153 is above the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

End stage renal disease (ESRD) patients on chronic dialysis.

Inclusion criteria

  • ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
153 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • HF (heart failure)

    Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction.

    Diagnostic Test: Diagnostic biomarker study

  • Control

    Patients with end stage renal disease requiring dialysis without HF.

    Diagnostic Test: Diagnostic biomarker study

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.

06

What researchers measure

Primary outcomes

  1. HF diagnosis

    Diagnosis of HF

    Time frame: Baseline (at study entry (diagnostic biomarker study))

07

Study locations

2 sites
  • Inserm Umr S-942
    Paris, France
  • Hannover Medical School
    Hannover, 30175, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04061811
Lead sponsor
Hannover Medical School
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France, F-CRIN
Responsible party
Michael Sören Balzer (Postdoctoral fellow, Hannover Medical School) — Principal investigator
First posted
Aug 20, 2019
Start date
Aug 1, 2018
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Aug 20, 2019

Study contacts

Michael S Balzer, MD
principal investigator · Hannover Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion