Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT03453151
Status:
COMPLETED
Last Update Posted:
2020-07-24
First Post:
2018-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Abdominal Nerve Blockade in Chronic Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marat.fudim@duke.edu', 'phone': '(919) 681-5816', 'title': 'Marat Fudim', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '48 hours after SNB', 'eventGroups': [{'id': 'EG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'notes': 'Diarrhea for \\<24 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostasis', 'notes': 'The first five patients had bilateral SNB and four of them developed symptomatic orthostatic hypotension (systolic blood pressure drop \\>20mmHg with 5 min standing). In all cases the orthostatic hypotension resolved with oral or intravenous hydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Before nerve block', 'categories': [{'measurements': [{'value': '9.1', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'After nerve block', 'categories': [{'measurements': [{'value': '9.8', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Peak VO2 will be measured before and after nerve block.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Pulmonary Arterial Pressure (mPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Before nerve block', 'categories': [{'measurements': [{'value': '40.5', 'spread': '12.3', 'groupId': 'OG000'}]}]}, {'title': 'After nerve block', 'categories': [{'measurements': [{'value': '32.7', 'spread': '13.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Mean pulmonary arterial pressure will be measured before and after nerve block.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pulmonary Capillary Wedge Pressure (PCWP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Steady state, before nerve block', 'categories': [{'measurements': [{'value': '28.3', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Steady state, after nerve block', 'categories': [{'measurements': [{'value': '20.3', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Peak exercise, before nerve block', 'categories': [{'measurements': [{'value': '34.8', 'spread': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Peak exercise, after nerve block', 'categories': [{'measurements': [{'value': '25.1', 'spread': '10.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Index (CI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Steady state, before nerve block', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Steady state, after nerve block', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Peak exercise, before nerve block', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Peak exercise, after nerve block', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This analysis refers to the resting cardiac index.'}, {'pValue': '0.069', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This analysis refers to the peak exercise cardiac index.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Cardiac index will be measured at 20 Watts steady state and peak exercise. Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual.', 'unitOfMeasure': 'L/min/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urine Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Before nerve block', 'categories': [{'measurements': [{'value': '167', 'spread': '174', 'groupId': 'OG000'}]}]}, {'title': 'After nerve block', 'categories': [{'measurements': [{'value': '297', 'spread': '180', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours pre-SNB, 2 hours post-SNB', 'description': 'Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Biomarker Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'classes': [{'title': 'Creatinine, before nerve block', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, after nerve block', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'BUN, before nerve block', 'categories': [{'measurements': [{'value': '19', 'spread': '10', 'groupId': 'OG000'}]}]}, {'title': 'BUN, after nerve block', 'categories': [{'measurements': [{'value': '18', 'spread': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.250', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This analysis refers to creatinine level.'}, {'pValue': '0.014', 'groupIds': ['OG000'], 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'This analysis refers to BUN level.'}], 'paramType': 'MEAN', 'timeFrame': '2 hours pre-SNB, 2 hours post-SNB', 'description': 'BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Splanchnic Nerve Block (SNB)', 'description': 'Splanchnic nerve anesthesia with a local anesthetic: regional nerve block with a local anesthetic (Lidocaine/Ropivacaine)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'N terminal pro BNP (B-type natriuretic peptide) level', 'classes': [{'categories': [{'measurements': [{'value': '2172', 'groupId': 'BG000', 'lowerLimit': '112', 'upperLimit': '9319'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-02', 'size': 497939, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-15T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-23', 'studyFirstSubmitDate': '2018-02-20', 'resultsFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-23', 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Peak VO2 will be measured before and after nerve block.'}, {'measure': 'Mean Pulmonary Arterial Pressure (mPAP)', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Mean pulmonary arterial pressure will be measured before and after nerve block.'}, {'measure': 'Pulmonary Capillary Wedge Pressure (PCWP)', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Index (CI)', 'timeFrame': 'baseline, up to 1 hour', 'description': 'Cardiac index will be measured at 20 Watts steady state and peak exercise. Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA), thus relating heart performance to the size of the individual.'}, {'measure': 'Urine Output', 'timeFrame': '2 hours pre-SNB, 2 hours post-SNB', 'description': 'Urine output will be measured in the 2 hours before the nerve block and in the 2 hours afterwards'}, {'measure': 'Renal Biomarker Levels', 'timeFrame': '2 hours pre-SNB, 2 hours post-SNB', 'description': 'BUN (blood urea nitrogen) and creatinine levels will be measured in the 2 hours before the nerve block and in the 2 hours afterwards.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '37449573', 'type': 'DERIVED', 'citation': 'Kittipibul V, Ganesh A, Coburn A, Coyne BJ, Gray JM, Molinger J, Ray N, Podgoreanu M, McCartney SL, Mamoun N, Fitzhugh RC, Lurz P, Green CL, Hernandez AF, Patel MR, Fudim M. Splanchnic Nerve Modulation Effects on Surrogate Measures of Venous Capacitance. J Am Heart Assoc. 2023 Jul 18;12(14):e028780. doi: 10.1161/JAHA.122.028780. Epub 2023 Jul 14.'}, {'pmid': '33714749', 'type': 'DERIVED', 'citation': 'Fudim M, Patel MR, Boortz-Marx R, Borlaug BA, DeVore AD, Ganesh A, Green CL, Lopes RD, Mentz RJ, Patel CB, Rogers JG, Felker GM, Hernandez AF, Sunagawa K, Burkhoff D. Splanchnic Nerve Block Mediated Changes in Stressed Blood Volume in Heart Failure. JACC Heart Fail. 2021 Apr;9(4):293-300. doi: 10.1016/j.jchf.2020.12.006. Epub 2021 Mar 10.'}, {'pmid': '32535123', 'type': 'DERIVED', 'citation': 'Fudim M, Boortz-Marx RL, Ganesh A, DeVore AD, Patel CB, Rogers JG, Coburn A, Johnson I, Paul A, Coyne BJ, Rao SV, Gutierrez JA, Kiefer TL, Kong DF, Green CL, Jones WS, Felker GM, Hernandez AF, Patel MR. Splanchnic Nerve Block for Chronic Heart Failure. JACC Heart Fail. 2020 Sep;8(9):742-752. doi: 10.1016/j.jchf.2020.04.010. Epub 2020 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'Patients with chronic heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves.\n\nThis study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.\n\nPatients will undergo detailed physiological testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of heart failure (HF)\n* Symptomatic with dyspnea\n* On a stable HF drug regimen\n\nExclusion Criteria:\n\n* Ongoing treatment with oral anticoagulation other than aspirin\n* Immunosuppressive medications for solid organ transplant\n* Acute MI (STEMI or Type I NSTEMI) within 7 days\n* Systolic blood pressure \\< 90 mmHg or \\>180 mmHg\n* Infiltrative cardiomyopathy or constrictive cardiomyopathy\n* Chronic kidney disease stage 5\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03453151', 'briefTitle': 'Abdominal Nerve Blockade in Chronic Heart Failure.', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF', 'orgStudyIdInfo': {'id': 'Pro00090299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regional nerve anesthesia', 'interventionNames': ['Drug: splanchnic nerve anesthesia with a local anesthetic']}], 'interventions': [{'name': 'splanchnic nerve anesthesia with a local anesthetic', 'type': 'DRUG', 'description': 'regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)', 'armGroupLabels': ['Regional nerve anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Manesh Patel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}