Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-04-09 @ 6:04 AM
Study NCT ID:
NCT02769351
Status:
TERMINATED
Last Update Posted:
2021-08-05
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014462', 'term': 'Ultrafiltration'}], 'ancestors': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.braun@fmc-ag.com', 'phone': '+49617260893488', 'title': 'Dr. Jennifer Braun', 'organization': 'Fresenius Medical Care Deutschland GmbH'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from signing the informed consent up to 12 month after recruitment.', 'description': 'Adverse Event Definition has been done according to a form based on ISO 14155', 'eventGroups': [{'id': 'EG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration\n\nperiph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 4, 'seriousNumAtRisk': 46, 'deathsNumAffected': 15, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palliative care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peritoneal catheter insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Demyelinating polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other Origin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration\n\nperiph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle'}], 'classes': [{'title': 'Rehospitalization due to Heart Failure', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Rehospitalization due to other reasons', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.', 'unitOfMeasure': 'Rehospitalizations', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome has been analyzed based on the AP (44 patients).'}, {'type': 'SECONDARY', 'title': 'Significant Deterioration of Kidney Function - Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration'}], 'classes': [{'title': 'Creatinine at Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '208.30', 'spread': '71.79', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine at Discharge from Index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '180.66', 'spread': '78.13', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine at Outpatient visit I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '224.99', 'spread': '162.7', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine at Outpatient visit II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '430.31', 'spread': '454.01', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome has been analyzed on the SP (46 patients). However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per time point.'}, {'type': 'SECONDARY', 'title': 'Significant Deterioration of Kidney Function - Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration'}], 'classes': [{'title': 'Urea at Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '15.01', 'groupId': 'OG000'}]}]}, {'title': 'Urea at Discharge from Index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.67', 'spread': '168.40', 'groupId': 'OG000'}]}]}, {'title': 'Urea at Outpatient visit I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '282.99', 'spread': '457.51', 'groupId': 'OG000'}]}]}, {'title': 'Urea at Outpatient visit II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome has been analyzed on the SP (46 patients). However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per time point and variable.'}, {'type': 'SECONDARY', 'title': 'Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration'}], 'classes': [{'title': 'eGFR at Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.58', 'spread': '15.56', 'groupId': 'OG000'}]}]}, {'title': 'eGFR at Discharge from Index hositalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.82', 'spread': '24.48', 'groupId': 'OG000'}]}]}, {'title': 'eGFR at Outaptient visit I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.19', 'spread': '30.87', 'groupId': 'OG000'}]}]}, {'title': 'eGFR at Outpatient visit II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.52', 'spread': '52.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).', 'unitOfMeasure': 'mL/min*1.73^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome has been analyzed on the SP (46 patients). However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per time point and variable.'}, {'type': 'SECONDARY', 'title': 'Significant Deterioration of Kidney Function - Cystatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration'}], 'classes': [{'title': 'Cystatin at Recruitment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Cystatin at Discharge from index Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Cystatin at Outpatient visit I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cystatin at Outpatient visit II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome has been analyzed on the SP (46 patients). However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per time point and variable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration\n\nperiph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'SP', 'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'SP', 'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}]}], 'recruitmentDetails': 'Out of 104 patients recruited, 46 patients have been included in the safety population (SP; all patients included in analysis), and 44 patients have been included in the analysis population (AP; patients included in analysis with at least one ultrafiltration treatment).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Periph. Minimal Invasive Ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration\n\nperiph. minimal invasive ultrafiltration: ultrafiltration via a peripheral single-needle'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74.71', 'spread': '10.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weight, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '90.19', 'spread': '21.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.'}, {'title': 'Height, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '171.93', 'spread': '10.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.'}, {'title': 'Body-Mass-Index (BMI), Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.03', 'spread': '5.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.However, due to the observational character of the study, data are not always available for all patients. The actual number of patients with available data is depicted per variable.'}], 'populationDescription': 'Baseline characteristics have been analyzed based on the analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-12-22', 'size': 260412, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-22T06:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'It was decided to prematurely terminate the GENTLE-UF registry as a parallel study conducted with the same device has been prematurely terminated due to low recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2016-03-21', 'resultsFirstSubmitDate': '2021-05-20', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-17', 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other Origin', 'timeFrame': '12 months', 'description': 'The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.'}], 'secondaryOutcomes': [{'measure': 'Significant Deterioration of Kidney Function - Creatinine', 'timeFrame': 'Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).'}, {'measure': 'Significant Deterioration of Kidney Function - Urea', 'timeFrame': 'Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).'}, {'measure': 'Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate)', 'timeFrame': 'Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).'}, {'measure': 'Significant Deterioration of Kidney Function - Cystatin', 'timeFrame': 'recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months)', 'description': 'Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['volume overload', 'heart failure', 'cardiac decompensation', 'ultrafiltration'], 'conditions': ['Acute Heart Failure', 'Cardiac Decompensation', 'Volume Overload']}, 'referencesModule': {'references': [{'pmid': '23747642', 'type': 'BACKGROUND', 'citation': 'Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.'}, {'pmid': '22828712', 'type': 'BACKGROUND', 'citation': 'McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.', 'detailedDescription': 'There may be various reasons why an increased accumulation of fluid occurs in tissue. The most common causes include heart failure, kidney failure or cirrhosis of the liver. In rare cases, oedema can develop following septicaemia. The usual treatment of oedema involves diuretics, i.e. water tablets, which remove excess fluid from the body and which can be administered either orally or intravenously. For some years now, it has also been possible to use ultrafiltration to treat oedema. This involves filtering and removing excess fluid from the blood. This individual method enables a precisely defined amount of fluid to be withdrawn. Access to the blood circulation is usually via a central venous catheter, as in acute dialysis. Current international treatment guidelines recommend that consideration should be given to ultrafiltration therapy in the context of treatment of diuretic-resistant volume overload (e.g. second- or third-line therapy for acute decompensated heart failure). There are, however, to date no clinical data on a combined treatment regimen of diuretics and supportive ultrafiltration. Accordingly, ultrafiltration may be included in clinical guidelines either only with a low level of evidence (e.g. IIb in the ACCF/AHA guidelines) or not at all (ESC guidelines). The main reasons for the limited body of evidence for ultrafiltration are, on the one hand, the invasive nature of the usual procedures (these usually require the insertion of a central venous catheter) and structural barriers in the health system (ultrafiltration is normally offered by nephrologists and not by cardiologists). With an increasing clinical need and limited medical alternatives, particularly in view of the frequently occurring diuretic resistance in heart failure, there is an urgent medical need to fill this gap in evaluation evidence. In the context of the registry, the CHIARA system, a minimally invasive (i.e. via a peripheral venous access) extracorporeal ultrafiltration system, is used for the treatment of decompensated volume overload. The CHIARA system has a CE mark for the intended purpose of ultrafiltration of the blood of patients suffering from heart failure, acute or chronic renal failure or excess body fluid. It is planned to use the medical device in connection with this intended purpose only. In participating hospitals, patients will be treated with this new treatment strategy of minimally invasive ultrafiltration treatment in support of diuretic drug therapy in the acute phase of volume overload. It is possible with the use of ultrafiltration therapy to control volume overload and reduce it on an individual basis, so that diuretics can be given sparingly and, as a consequence, diuretic resistance and a deterioration of renal function due to diuretic uptitration can be avoided.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with minimally invasive ultrafiltration in support of diuretic drug therapy in the acute phase of volume overload.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥18 years\n* Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. ≥80 mg furosemide / 24 h or less than 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics \\[established clinically or from the medical history\\])\n* New York Association Functional Class (NYHA) III-IV at inclusion\n* Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF)\n* Adequate venous access (preferably peripheral arm vein) allowing a flow rate ≥ 60 mL / min\n* Written consent to the use of data in the registry (where necessary, by a legal guardian).\n\nExclusion Criteria:\n\n* Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding)\n* Terminal renal failure (stage V, GFR \\<15 mL)\n* Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS)\n* Other diseases or factors that, in the study doctor's opinion, constitute a potential contraindication to ultrafiltration\n* Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception."}, 'identificationModule': {'nctId': 'NCT02769351', 'acronym': 'GENTLE-UF', 'briefTitle': 'Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Medical Care Deutschland GmbH'}, 'officialTitle': 'A Multicentre, Prospective Registry to Evaluate the Safety and Efficacy of Minimally Invasive Ultrafiltration Treatment and Its Effect on Symptoms and Rehospitalisation in Patients With Advanced Volume Overload', 'orgStudyIdInfo': {'id': 'UF-HF-01-INT'}, 'secondaryIdInfos': [{'id': 'DRKS00009836', 'type': 'REGISTRY', 'domain': 'DRKS: German Clinical Trials Register'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'periph. minimal invasive ultrafiltration', 'description': 'Patients with volume overload receiving ultrafiltration', 'interventionNames': ['Device: periph. minimal invasive ultrafiltration']}], 'interventions': [{'name': 'periph. minimal invasive ultrafiltration', 'type': 'DEVICE', 'otherNames': ['ultrafiltration'], 'description': 'ultrafiltration via a peripheral single-needle', 'armGroupLabels': ['periph. minimal invasive ultrafiltration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '76185', 'city': 'Karlsruhe', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Helios Klinik für Herzchirurgie GmbH Karlsruhe', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '70174', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Klinikum Stuttgart', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '38126', 'city': 'Braunschweig', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Städtisches Klinikum Braunschweig', 'geoPoint': {'lat': 52.26594, 'lon': 10.52673}}, {'zip': '31135', 'city': 'Hildesheim', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Helios Klinikum Hildesheim', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uniklinik RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '57439', 'city': 'Attendorn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Helios Klinik Attendorn', 'geoPoint': {'lat': 51.12645, 'lon': 7.90333}}, {'zip': '47053', 'city': 'Duisburg', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Helios Klinikum Duisburg', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '99089', 'city': 'Erfurt', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'HELIOS Klinikum Erfurt', 'geoPoint': {'lat': 50.97734, 'lon': 11.03536}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Helios Klinikum Berlin Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79182', 'city': 'Falun', 'country': 'Sweden', 'facility': 'Falun Hospital', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'SUS Skanes University Hosptal', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'University Hospital Örebro', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyd University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Henning T Baberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helios Klinikum Berlin Buch, Berlin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Overall results will be published. Individual participant data will not be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Medical Care Deutschland GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}