Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

DKK3 for Prognosis and Monitoring of GFR Loss in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04111094
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Giessen

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) loss are needed. Recently, urinary dickkopf-3 (DKK3) has been proposed to predict eGFR loss in patients with CKD, independent of presence of albuminuria. The investigators sought to examine the association between DKK3 and loss of eGFR in patients with heart failure (HF). The investigators hypothesized that changes in DKK3 under treatment may be helpful to monitor individual kidney disease course.

Condition or disease Intervention/treatment
Heart Failure Chronic Kidney Diseases Diagnostic Test: No intervention

Detailed 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) loss are needed. Recently, urinary dickkopf-3 (DKK3) has been identified as a stress-induced, renal tubular epithelia-derived, secreted glycoprotein that induces tubulointerstitial fibrosis. Urinary DKK3 has been found to predict eGFR loss in patients with CKD, independent of presence of albuminuria. The investigators sought to examine the association between DKK3 and loss of eGFR in patients with heart failure (HF). Also, the investigators hypothesized that changes in DKK3 under treatment may be helpful to monitor individual kidney disease course.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Dickkopf-3 for Prognosis and Monitoring of Glomerular Filtration Rate Loss in Patients With Heart Failure
Actual Study Start Date : October 14, 2019
Estimated Primary Completion Date : October 13, 2020
Estimated Study Completion Date : October 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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.
Diagnostic Test: No intervention
No intervention

Diabetes
Diagnosed diabetes mellitus, with/without treatment
Diagnostic Test: No intervention
No intervention

Hypertension
Diagnosed hypertension, with/without treatment
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. eGFR loss [ Time Frame: 12 months ]
    eGFR (CKD-Epidemiology Collaboration equation)


Secondary Outcome Measures :
  1. Association of tubular proteinuria with DKK3 [ Time Frame: 12 months ]
    alpha 1 microglobulin/creatinine ratio

  2. Persistent or worsening of HF [ Time Frame: 12 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: 12 months ]
    Requirement of incident renal replacement therapy

  4. Association of venous congestion with DKK3 [ Time Frame: 12 months ]
    b-type natriuretic peptide, clinical examination

  5. Association of right and left ventricular function with DKK3 [ Time Frame: 12 months ]
    echocardiography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension
Criteria

Inclusion Criteria:

  • Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension

Exclusion Criteria:

  • CKD stage with estimated GFR <15 ml/min/1.73 m2
  • pre-existing acute kidney injury
  • non-end stage renal disease with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload
  • pre-diagnosed glomerulonephritis
  • pyelonephritis
  • autosomal dominant polycystic kidney disease
  • postrenal obstruction
  • active tumor disease
  • inflammatory or autoimmune disease requiring systemic immunosuppressive treatment
  • serum high-sensitivity C-reactive protein >20mg/l
  • recipients of solid-organ transplants
  • patients who received non-steroidal anti-inflammatory drugs or intravenous contrast media within 72 hours prior to recruitment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111094


Contacts
Layout table for location contacts
Contact: Faeq Husain-Syed, MD 004964198542378 faeqhusain@yahoo.de
Contact: Horst-Walter Birk, MD 004964198542378 horst-walter.birk@innere.med.uni-giessen.de

Locations
Layout table for location information
Germany
University Clinic Giessen and Marburg - Campus Giessen Recruiting
Giessen, Hessen, Germany, 35392
Contact: Faeq Husain-Syed, MD    +49 641 985 42378    faeqhusain@yahoo.de   
Contact: Horst-Walter Birk, MD    +49 641 985 4278    horst-walter.birk@innere.med.uni-giessen.de   
Sponsors and Collaborators
University of Giessen
Investigators
Layout table for investigator information
Study Chair: Werner Seeger, MD University Hospital Giessen

Publications:
Layout table for additonal information
Responsible Party: University of Giessen
ClinicalTrials.gov Identifier: NCT04111094    
Other Study ID Numbers: AZ 122/19
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency