DIAGNOSTIC_TEST
No intervention
No intervention
DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure
Status
Completed
Phase
Not applicable
Enrollment
290
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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).
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 1, 2019
Study start
Oct 14, 2019
Primary completion
Jan 21, 2023
Study completion
May 6, 2024
Results posted
Not reported
Registry updated
May 9, 2024
Outcomes
What the study measures.
Primary outcomes
Association between DKK3 and eGFR decline
Time frame · 24 months
DKK3 and eGFR (CKD-Epidemiology Collaboration equation)
Secondary outcomes
Association between proteinuria and DKK3
Time frame · 24 months
DKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion
Persistent or worsening of HF
Time frame · 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)
Need for renal replacement therapy
Time frame · 24 months
Requirement of incident renal replacement therapy
Association of venous congestion/volume overload with DKK3
Time frame · 24 months
B-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography
Association of right and left ventricular function with DKK3
Time frame · 24 months
Echocardiography
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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
Study locations
1 registered sites.
Germany. Showing up to 24 locations stored in the fast local snapshot.
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, Germany
Publications
Results and literature.
PMID 30279273 ↗Zewinger S, Rauen T, Rudnicki M, Federico G, Wagner M, Triem S, Schunk SJ, Petrakis I, Schmit D, Wagenpfeil S, Heine GH, Mayer G, Floege J, Fliser D, Grone HJ, Speer T. Dickkopf-3 (DKK3) in Urine Identifies Patients with Short-Term Risk of eGFR Loss. J Am Soc Nephrol. 2018 Nov;29(11):2722-2733. doi: 10.1681/ASN.2018040405. Epub 2018 Oct 2.PMID 27699213 ↗Federico G, Meister M, Mathow D, Heine GH, Moldenhauer G, Popovic ZV, Nordstrom V, Kopp-Schneider A, Hielscher T, Nelson PJ, Schaefer F, Porubsky S, Fliser D, Arnold B, Grone HJ. Tubular Dickkopf-3 promotes the development of renal atrophy and fibrosis. JCI Insight. 2016 Jan 21;1(1):e84916. doi: 10.1172/jci.insight.84916.
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