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

NCT ID: NCT04061811

Last Updated: 2019-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-02-28

Brief Summary

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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

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Conditions

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Heart Failure End Stage Renal Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HF (heart failure)

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

Diagnostic biomarker study

Intervention Type DIAGNOSTIC_TEST

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 biomarker study

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

F-CRIN

UNKNOWN

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Michael Sören Balzer

Postdoctoral fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Balzer, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Inserm Umr S-942

Paris, , France

Site Status

Hannover Medical School

Hanover, , Germany

Site Status

Countries

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France Germany

Other Identifiers

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KlinStrucMed program

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

7952_BO_S_2018

Identifier Type: -

Identifier Source: org_study_id

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