DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

University of Giessen

Status: Completed

Conditions: Chronic Kidney Diseases; Heart Failure

Treatments: Diagnostic Test: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04111094

AZ 122/19

Details and patient eligibility

About

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 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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

290 participants in 6 patient groups

HF

Description:

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.

Treatment:

Diagnostic Test: No intervention

Diabetes mellitus/hypertension

Description:

Diagnosed diabetes mellitus, with/without treatment

Treatment:

Diagnostic Test: No intervention

Hypertension

Description:

Diagnosed hypertension, with/without treatment

Treatment:

Diagnostic Test: No intervention

Cystic kidney diseases

Description:

Diagnosed cystic kidney diseases, with/without treatment

Treatment:

Diagnostic Test: No intervention

Tubulointerstitial diseases

Description:

Diagnosed tubulointerstitial diseases, with/without treatment

Treatment:

Diagnostic Test: No intervention

Glomerular diseases

Description:

Diagnosed glomerular diseases, with/without treatment

Treatment:

Diagnostic Test: No intervention