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Completed

NCT Number: NCT04111094

DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Diagnostic Test

No intervention

Primary outcomes

  1. Association between DKK3 and eGFR decline

    Time frame: 24 months

    DKK3 and eGFR (CKD-Epidemiology Collaboration equation)

Secondary outcomes

  1. Association between proteinuria and DKK3

    Time frame: 24 months

    DKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion

  2. 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)

  3. Need for renal replacement therapy

    Time frame: 24 months

    Requirement of incident renal replacement therapy

  4. Association of venous congestion/volume overload with DKK3

    Time frame: 24 months

    B-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography

  5. Association of right and left ventricular function with DKK3

    Time frame: 24 months

    Echocardiography

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Oct 1, 2019
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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