Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT04111094
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between DKK3 and eGFR decline', 'timeFrame': '24 months', 'description': 'DKK3 and eGFR (CKD-Epidemiology Collaboration equation)'}], 'secondaryOutcomes': [{'measure': 'Association between proteinuria and DKK3', 'timeFrame': '24 months', 'description': 'DKK3 and proteinuria, albuminuria, and alpha 1 microglobulin excretion'}, {'measure': 'Persistent or worsening of HF', 'timeFrame': '24 months', 'description': '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)'}, {'measure': 'Need for renal replacement therapy', 'timeFrame': '24 months', 'description': 'Requirement of incident renal replacement therapy'}, {'measure': 'Association of venous congestion/volume overload with DKK3', 'timeFrame': '24 months', 'description': 'B-type natriuretic peptide, clinical examination, bioimpedance analysis, echocardiography'}, {'measure': 'Association of right and left ventricular function with DKK3', 'timeFrame': '24 months', 'description': 'Echocardiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '30279273', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27699213', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension or other etiologies of CKD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients ≥18 years of age with diagnosed HF or diabetes or hypertension\n\nExclusion Criteria:\n\n* CKD with estimated GFR \\<20 ml/min/1.73 m2 (2012 CKD-EPI equation)\n* CKD with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload\n* active tumor disease\n* inflammatory or autoimmune disease requiring systemic immunosuppressive treatment\n* clinically apparent infections\n* recipients of solid-organ transplants\n* anticipated life expectancy of \\<12 months\n* likelihood of receiving advanced therapy (mechanical circulatory assist device/cardiac transplant)\n* pregnancy or possibility of pregnancy in the next 12 months'}, 'identificationModule': {'nctId': 'NCT04111094', 'briefTitle': 'DKK3 for Prognosis and Monitoring of GFR Decline in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Urinary Dickkopf-3 for Prognosis and Monitoring of Glomerular Filtration Rate Decline in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'AZ 122/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Diagnostic Test: No intervention']}, {'label': 'Diabetes mellitus/hypertension', 'description': 'Diagnosed diabetes mellitus, with/without treatment', 'interventionNames': ['Diagnostic Test: No intervention']}, {'label': 'Hypertension', 'description': 'Diagnosed hypertension, with/without treatment', 'interventionNames': ['Diagnostic Test: No intervention']}, {'label': 'Cystic kidney diseases', 'description': 'Diagnosed cystic kidney diseases, with/without treatment', 'interventionNames': ['Diagnostic Test: No intervention']}, {'label': 'Tubulointerstitial diseases', 'description': 'Diagnosed tubulointerstitial diseases, with/without treatment', 'interventionNames': ['Diagnostic Test: No intervention']}, {'label': 'Glomerular diseases', 'description': 'Diagnosed glomerular diseases, with/without treatment', 'interventionNames': ['Diagnostic Test: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'DIAGNOSTIC_TEST', 'description': 'No intervention', 'armGroupLabels': ['Cystic kidney diseases', 'Diabetes mellitus/hypertension', 'Glomerular diseases', 'HF', 'Hypertension', 'Tubulointerstitial diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Clinic Giessen and Marburg - Campus Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'overallOfficials': [{'name': 'Werner Seeger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Giessen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}