DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure

NCT ID: NCT04111094

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2024-05-06

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Heart Failure Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Diabetes mellitus/hypertension

Diagnosed diabetes mellitus, with/without treatment

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Hypertension

Diagnosed hypertension, with/without treatment

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Cystic kidney diseases

Diagnosed cystic kidney diseases, with/without treatment

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Tubulointerstitial diseases

Diagnosed tubulointerstitial diseases, with/without treatment

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Glomerular diseases

Diagnosed glomerular diseases, with/without treatment

No intervention

Intervention Type DIAGNOSTIC_TEST

No intervention

Interventions

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No intervention

No intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Giessen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Seeger, MD

Role: STUDY_CHAIR

University Hospital Giessen

Locations

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University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 30279273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27699213 (View on PubMed)

Other Identifiers

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AZ 122/19

Identifier Type: -

Identifier Source: org_study_id

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