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

Completed

• Conditions: End Stage Renal Disease; Heart Failure
• Interventions: Diagnostic Test: Diagnostic biomarker study

• Registration Number: NCT04061811
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2019-08
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-19
• Last Update Submitted: 2019-08-19
• Study First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
HF diagnosis	Baseline (at study entry (diagnostic biomarker study))	Diagnosis of HF

Trial Locations

Locations (2)

Hannover Medical School; 🇩🇪 Hannover, Germany

Inserm Umr S-942; 🇫🇷 Paris, France