Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 7:26 PM
Study NCT ID:
NCT02079259
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in central venous pressure', 'timeFrame': 'Changes from Baseline to 48 h after intervention'}], 'secondaryOutcomes': [{'measure': 'amount of net fluid loss', 'timeFrame': '48 h'}, {'measure': 'Measure of dyspnea using a visual analog scale', 'timeFrame': 'Changes from Baseline to 48 h after intervention'}, {'measure': 'heart function', 'timeFrame': '7 days', 'description': 'right/left heart function measured by Echocardiography and BNP (Brain Natriuretic Peptide)'}, {'measure': 'Biomarker', 'timeFrame': 'Changes from Baseline to 48 h after intervention', 'description': 'GFR, Cystatin C, HCO3-, NT-proBNP, CK, Troponin, Hematocrit'}, {'measure': 'Time until impaired plasma refill rate', 'timeFrame': '48 h'}, {'measure': 'blood pressure', 'timeFrame': 'Changes from Baseline to 48 h after intervention'}, {'measure': 'heart rate', 'timeFrame': 'Changes from Baseline to 48 h after intervention'}, {'measure': 'Serum Creatinine level', 'timeFrame': '48 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance.\n\nThere is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration.\n\nAquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic heart failure listed for LVAD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic heart failure scheduled for LVAD\n* Indication for CVVH/Aquapheresis\n\nExclusion Criteria:\n\n* Renal Disease (GFR \\<20 ml / min)'}, 'identificationModule': {'nctId': 'NCT02079259', 'acronym': 'Aquadex', 'briefTitle': 'CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure - A Pilot Study to Optimize Individualized Volume Depletion', 'orgStudyIdInfo': {'id': 'Aquadex'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrafiltration', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Ralf Westenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf'}, {'name': 'Malte Kelm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Dusseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}