Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02372292
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059347', 'term': 'Cardio-Renal Syndrome'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'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': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005665', 'term': 'Furosemide'}], 'ancestors': [{'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alterations in the renal arterial resistivity index', 'timeFrame': 'during hospitalization, an expected average of 4 weeks.', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.'}], 'secondaryOutcomes': [{'measure': 'Alterations in the renal venous impedance index', 'timeFrame': 'during hospitalization, an expected average of 4 weeks.', 'description': 'Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiorenal syndrome, decompensated heart failure, renal resistivity index, venous impedance index, kidney failure'], 'conditions': ['Cardiorenal Syndrome']}, 'descriptionModule': {'briefSummary': 'Although the traditional determinant of renal dysfunction in heart failure was suggested as decreased cardiac output and renal hypo perfusion, recent studies have demonstrated the association of persistent systemic venous congestion and kidney dysfunction. Relief of the congestion has demonstrated to improve renal functions in decompensated heart failure. The current trial was set up to investigate the changes of renal venous impedance and renal arteriolar resistivity indices with diuretic therapy, in patients with congestive renal failure. The investigators asked whether measurement of renal venous impedance index or renal arteriolar resistivity index can guide the practice of diuretic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decompensated heart failure\n* Elevated serum creatinine levels on admission\n\nExclusion Criteria:\n\n* Atrial fibrillation\n* Obstructive uropathy\n* Patients with ascites\n* Patients who exposed the potential nephrotoxic drugs in the previous week (metformin, antibiotics, chemotherapeutics, iodinated contrast agents and non-steroidal anti-inflammatory agents)\n* Patients who needed positive inotropic agents'}, 'identificationModule': {'nctId': 'NCT02372292', 'briefTitle': 'Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Value of Renal Vascular Doppler Sonography in Management of Decompensated Heart Failure', 'orgStudyIdInfo': {'id': 'Ankararenal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Patients with type 1 cardiorenal syndrome who had improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.', 'interventionNames': ['Drug: intravenous furosemide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Patients with type 1 cardiorenal syndrome who did not have improvement of renal functions along with diuretic therapy. Intravenous furosemide treatment.', 'interventionNames': ['Drug: intravenous furosemide']}], 'interventions': [{'name': 'intravenous furosemide', 'type': 'DRUG', 'otherNames': ['Lasix'], 'description': 'Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University School Of Medicine, Department of Cardiology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Özgür Ulaş Özcan', 'investigatorAffiliation': 'Ankara University'}}}}