An observational study in Heart Failure and Chronic Kidney Diseases, sponsored by University of Giessen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of Giessen · Observational
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).
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 290 is above the median of 192 across 1,033 observational studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Giessen is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension or other etiologies of CKD
Exclusion Criteria:
Diagnosed heart failure as described by recent guidelines. Inclusion criteria will be applied: i) minimum one symptom typical of HF: positive physical examination (e.g., bilateral oedema, increased jugular pressure) or positive clinical history (e.g., orthopnoea, history of coronary vascular disease, history of arterial hypertension, exposition to cardiotoxic drug/radiation, diuretic use); b-type natriuretic peptide (BNP) or N-terminal pro-BNP levels ≥35 or ≥125 pg/ml, respectively; and iii) classification as New York Heart Association (NYHA) functional class 2 or 3. There is no prespecified inclusion criterion with respect to left ventricular ejection fraction as congestive symptoms and prevalence of kidney dysfunction are comparable in patients with HF across the left ventricular ejection fraction spectrum.
Diagnostic Test: No intervention
Diagnosed diabetes mellitus, with/without treatment
Diagnostic Test: No intervention
Diagnosed hypertension, with/without treatment
Diagnostic Test: No intervention
Diagnosed cystic kidney diseases, with/without treatment
Diagnostic Test: No intervention
Diagnosed tubulointerstitial diseases, with/without treatment
Diagnostic Test: No intervention
Diagnosed glomerular diseases, with/without treatment
Diagnostic Test: No intervention
No intervention
Association between DKK3 and eGFR decline
DKK3 and eGFR (CKD-Epidemiology Collaboration equation)
Time frame: 24 months
Association between proteinuria and DKK3
DKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion
Time frame: 24 months
Persistent or worsening of HF
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)
Time frame: 24 months
Need for renal replacement therapy
Requirement of incident renal replacement therapy
Time frame: 24 months
Association of venous congestion/volume overload with DKK3
B-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography
Time frame: 24 months
Association of right and left ventricular function with DKK3
Echocardiography
Time frame: 24 months
Plan to share: Undecided
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Giessen