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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

290

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.6 years study duration

First Submitted

Initial submission to the registry

September 27, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed

13 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed

3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed

Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

September 27, 2019

Last Update Submit

May 7, 2024

Conditions

Heart Failure Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

Association between DKK3 and eGFR decline
DKK3 and eGFR (CKD-Epidemiology Collaboration equation)
24 months

Secondary Outcomes (5)

Association between proteinuria and DKK3
24 months
Persistent or worsening of HF
24 months
Need for renal replacement therapy
24 months
Association of venous congestion/volume overload with DKK3
24 months
Association of right and left ventricular function with DKK3
24 months

Study Arms (6)

HF

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.