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

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ClinicalTrials.gov Identifier: NCT04061811
Recruitment Status : Completed
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
F-CRIN
Information provided by (Responsible Party):
Michael Sören Balzer, Hannover Medical School

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.


Condition or disease Intervention/treatment
Heart Failure End Stage Renal Disease Diagnostic Test: Diagnostic biomarker study

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
HF (heart failure)
Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction.
Diagnostic Test: Diagnostic 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.

Control
Patients with end stage renal disease requiring dialysis without HF.
Diagnostic Test: Diagnostic 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.




Primary Outcome Measures :
  1. HF diagnosis [ Time Frame: Baseline (at study entry (diagnostic biomarker study)) ]
    Diagnosis of HF


Biospecimen Retention:   Samples Without DNA
Plasma, serum, peritoneal dialysate.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
End stage renal disease (ESRD) patients on chronic dialysis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061811


Locations
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France
Inserm Umr S-942
Paris, France
Germany
Hannover Medical School
Hannover, Germany, 30175
Sponsors and Collaborators
Hannover Medical School
Institut National de la Santé Et de la Recherche Médicale, France
F-CRIN
Investigators
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Principal Investigator: Michael S Balzer, MD Hannover Medical School

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Responsible Party: Michael Sören Balzer, Postdoctoral fellow, Hannover Medical School
ClinicalTrials.gov Identifier: NCT04061811     History of Changes
Other Study ID Numbers: 7952_BO_S_2018
KlinStrucMed program ( Other Grant/Funding Number: Else Kröner-Fresenius-Stiftung )
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Sören Balzer, Hannover Medical School:
congestive heart failure (HF)
biomarker
chronic kidney disease (CKD)
hemodialysis (HD)
peritoneal dialysis (PD)
neprilysin (NEP)
growth differentiation factor-15 (GDF15)
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency