DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

Completed

• Conditions: Heart Failure; Chronic Kidney Diseases

• Registration Number: NCT04111094
• Lead Sponsor: University of Giessen

Brief Summary

The individual course of chronic kidney disease (CKD) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (eGFR) decline are needed. Recently, urinary dickkopf-3 (DKK3) has been proposed to predict eGFR decline in patients with CKD, independent of presence of albuminuria. The investigators sought to examine the association between changes in DKK3 levels and eGFR decline in patients with heart failure (HF).

Detailed Description

The individual course of chronic kidney disease (CKD) may vary, and improved methods for identifying which patients will experience estimated glomerular filtration rate (eGFR) decline are needed. Recently, urinary dickkopf-3 (DKK3) has been identified as an stress-induced, renal tubular epithelia-derived, secreted glycoprotein that induces tubulointerstitial fibrosis. Urinary DKK3 has been found to predict eGFR decline in patients with CKD, independent of presence of albuminuria, but its association with eGFR decline in patients with heart failure (HF) is unknown. The investigators sought to examine the association between changes in DKK3 and eGFR decline in patients with HF.

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2019-10-14
• Primary Completion: 2023-01-21
• Status Verified: 2024-05
• Study Completion: 2024-05-06
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension

Exclusion Criteria

• CKD with estimated GFR <20 ml/min/1.73 m2 (2012 CKD-EPI equation)
• CKD with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload
• active tumor disease
• inflammatory or autoimmune disease requiring systemic immunosuppressive treatment
• clinically apparent infections
• recipients of solid-organ transplants
• anticipated life expectancy of <12 months
• likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)
• pregnancy or possibility of pregnancy in the next 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association between DKK3 and eGFR decline	24 months	DKK3 and eGFR (CKD-Epidemiology Collaboration equation)

Secondary Outcome Measures

Name	Time	Method
Association between proteinuria and DKK3	24 months	DKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion
Persistent or worsening of HF	24 months	Cardiovascular death, hospital admission for decompensated HF, or clinical HF decompensation without hospital admission (but requiring parenteral HF therapy or changes in oral HF medications including diuretics)
Association of venous congestion/volume overload with DKK3	24 months	B-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography
Need for renal replacement therapy	24 months	Requirement of incident renal replacement therapy
Association of right and left ventricular function with DKK3	24 months	Echocardiography

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Giessen, Hessen, Germany