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DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

Urinary Dickkopf-3 for Prognosis and Monitoring of Glomerular Filtration Rate Decline in Patients With Heart Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04111094
Enrollment
290
Registered
2019-10-01
Start date
2019-10-14
Completion date
2024-05-06
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Heart Failure

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.

Interventions

DIAGNOSTIC_TESTNo intervention

No intervention

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Association between DKK3 and eGFR decline24 monthsDKK3 and eGFR (CKD-Epidemiology Collaboration equation)

Secondary

MeasureTime frameDescription
Association of right and left ventricular function with DKK324 monthsEchocardiography
Association between proteinuria and DKK324 monthsDKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion
Persistent or worsening of HF24 monthsCardiovascular 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)
Need for renal replacement therapy24 monthsRequirement of incident renal replacement therapy
Association of venous congestion/volume overload with DKK324 monthsB-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026