Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-29 @ 9:16 AM
Study NCT ID:
NCT01625403
Status:
UNKNOWN
Last Update Posted:
2012-08-07
First Post:
2012-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant BNP on Heart and Renal Function in Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-05', 'studyFirstSubmitDate': '2012-06-19', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'left ventricular systolic function', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'serum creatinine', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recombinant BNP', 'Diuretics', 'Acute decompensated heart failure', 'Acute renal injury', 'Heart function', 'Renal function'], 'conditions': ['Acute Heart Failure', 'Acute Renal Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of recombinant human B-type natriuretic peptide (rhBNP) on heart and renal function in patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI).', 'detailedDescription': 'Patients with acute decompensated heart failure (ADHF) and acute renal injury (AKI) will be randomized to receive standard of care with or without additional rhBNP.\n\nClinical heart function, LVEF, SCr, GFR and other laboratory parameters will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute heart failure with acute renal injury\n\nExclusion Criteria:\n\n* not tolerate to rhBNP'}, 'identificationModule': {'nctId': 'NCT01625403', 'briefTitle': 'Recombinant BNP on Heart and Renal Function in Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Effect of Recombinant BNP on Heart and Renal Function in Acute Decompensated Heart Failure Patients With Acute Renal Injury', 'orgStudyIdInfo': {'id': 'SHCHESTCCU01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rhBNP treated', 'description': 'standard of care with rhBNP', 'interventionNames': ['Drug: rhBNP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard of care', 'description': 'standard of care', 'interventionNames': ['Drug: standard of care']}], 'interventions': [{'name': 'rhBNP', 'type': 'DRUG', 'description': 'intravenous administration of rhBNP 0.01 µg/kg/min', 'armGroupLabels': ['rhBNP treated']}, {'name': 'standard of care', 'type': 'DRUG', 'description': 'standard of care for heart failure', 'armGroupLabels': ['standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Yuan', 'role': 'CONTACT', 'email': 'yuanfangysh@126.com'}, {'name': 'Fang Yuan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Fang Yuan', 'role': 'CONTACT', 'email': 'yuanfangysh@126.com'}], 'overallOfficials': [{'name': 'Fang Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Fang Yuan', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}