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

Heart Failure Clinical Trial

— SONGBIRD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061811
• Other study ID #: 7952_BO_S_2018
• Secondary ID: KlinStrucMed pro
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: August 2019
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Heart Failure
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
France	Inserm Umr S-942	Paris
Germany	Hannover Medical School	Hannover

Sponsors (3)

Lead Sponsor	Collaborator
Hannover Medical School	F-CRIN, Institut National de la Santé Et de la Recherche Médicale, France

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HF diagnosis	Diagnosis of HF	Baseline (at study entry (diagnostic biomarker study))