Soluble Neprilysin, NT-proBNP, and Growth-Differentiation-Factor-15 as Biomarkers for Heart Failure in Dialysis Patients
SONGBIRD
2 other identifiers
observational
153
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
August 16, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedAugust 20, 2019
August 1, 2019
7 months
August 16, 2019
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HF diagnosis
Diagnosis of HF
Baseline (at study entry (diagnostic biomarker study))
Study Arms (2)
HF (heart failure)
Patients with end stage renal disease requiring dialysis with reduced or preserved ejection fraction.
Control
Patients with end stage renal disease requiring dialysis without HF.
Interventions
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.
Eligibility Criteria
End stage renal disease (ESRD) patients on chronic dialysis.
You may qualify if:
- ESRD on either chronic hemodialysis (HD) or peritoneal dialysis (PD) for ≥3 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- Institut National de la Santé Et de la Recherche Médicale, Francecollaborator
- F-CRINcollaborator
Study Sites (2)
Inserm Umr S-942
Paris, France
Hannover Medical School
Hanover, 30175, Germany
Biospecimen
Plasma, serum, peritoneal dialysate.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Balzer, MD
Hannover Medical School
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral fellow
Study Record Dates
First Submitted
August 16, 2019
First Posted
August 20, 2019
Study Start
August 1, 2018
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share