Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-01-01 @ 5:12 AM
Study NCT ID:
NCT04575428
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2020-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)
Sponsor:
Organization:
Raw JSON
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Not related to the baseline intervention done a month earlier. Self limited. Patient had no lasting complications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Exercise Wedge Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Pre nerve block', 'categories': [{'measurements': [{'value': '44', 'spread': '6.2', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '34', 'spread': '8.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measured with cardiopulmonary exercise testing', 'unitOfMeasure': 'Mmhg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Peak Pulmonary Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '56', 'spread': '9.2', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '47', 'spread': '10.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measured on exercise cardiopulmonary stress test', 'unitOfMeasure': 'Mmhg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Absence of Nerve Block Related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Assessment of orthostasis, gastrointestinal symptoms were observed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Oxygen Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.5', 'spread': '2', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '9.1', 'spread': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'mL/min/m2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Wedge Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.5', 'spread': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '14', 'spread': '1.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Assessed with right heart cath', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Central Venous Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.3', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Assessed with right heart cath', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Resting Pulmonary Arterial Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24', 'spread': '9', 'groupId': 'OG000'}]}]}, {'title': 'Post nerve block', 'categories': [{'measurements': [{'value': '20', 'spread': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Assessed on right heart catheterization', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dyspnea - Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '76', 'spread': '11', 'groupId': 'OG000'}]}]}, {'title': 'After nerve block', 'categories': [{'measurements': [{'value': '81', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The VAS for dyspnea has a range of 0 to 100, where 0 corresponds to the patient\'s subjective feeling of "I Can Breathe Normally" and a score of 100 corresponds to "I Can\'t Breathe At All."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Splanchnic Nerve Block', 'description': 'Splanchnic nerve block: Percutaneous splanchnic nerve block'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', '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', 'unitOfMeasure': 'Participants'}, {'title': 'Left ventricular ejection fraction >55%', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-01', 'size': 480964, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-17T18:20', 'hasProtocol': True}, {'date': '2022-05-13', 'size': 293266, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-06-21T16:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-21', 'studyFirstSubmitDate': '2020-08-20', 'resultsFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2020-10-02', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-19', 'studyFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Exercise Wedge Pressure', 'timeFrame': '4 weeks', 'description': 'Measured with cardiopulmonary exercise testing'}, {'measure': 'Peak Pulmonary Arterial Pressure', 'timeFrame': '4 weeks', 'description': 'Measured on exercise cardiopulmonary stress test'}, {'measure': 'Absence of Nerve Block Related Complications', 'timeFrame': '8 weeks', 'description': 'Assessment of orthostasis, gastrointestinal symptoms were observed'}], 'secondaryOutcomes': [{'measure': 'Peak Oxygen Uptake', 'timeFrame': '4 weeks'}, {'measure': 'Resting Wedge Pressure', 'timeFrame': '4 weeks', 'description': 'Assessed with right heart cath'}, {'measure': 'Resting Central Venous Pressure', 'timeFrame': '4 weeks', 'description': 'Assessed with right heart cath'}, {'measure': 'Resting Pulmonary Arterial Pressure', 'timeFrame': '4 weeks', 'description': 'Assessed on right heart catheterization'}, {'measure': 'Dyspnea - Visual Analog Scale (VAS)', 'timeFrame': '4 weeks', 'description': 'The VAS for dyspnea has a range of 0 to 100, where 0 corresponds to the patient\'s subjective feeling of "I Can Breathe Normally" and a score of 100 corresponds to "I Can\'t Breathe At All."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure, exercise, splanchnic nerve block'], 'conditions': ['Chronic Heart Failure']}, 'descriptionModule': {'briefSummary': 'Splanchnic vasoconstriction may contribute to decompensation of chronic heart failure (HF) via volume redistribution from the splanchnic vascular bed to the central compartment. This is a sympathetically mediated reflex and can be interrupted through a splanchnic nerve block (SNB). We hypothesize that interruption of the efferent/afferent innervation of the splanchnic vasculature will decrease cardiac congestion in patients presenting with HF. Based on preliminary safety and efficacy data in acute and chronic heart failure patients with temporary (\\<24 h) SNB. Now we will apply a prolonged SNB in chronic heart failure patients using a long acting agent. We will test the effects of SNB on long term exercise capacitance.', 'detailedDescription': 'Activation of splanchnic nerves results in vasoconstriction and reduces splanchnic capacitance, therefore recruiting blood volume into the central circulation. In heart failure, a reduced splanchnic vascular capacitance could be the mechanism underlying symptoms of exercise intolerance and could predispose to rapid decompensation with external fluid intake or retention. A compromised vascular reservoir is likely unable to buffer shifts of fluid and actively contributes to the acute or chronic expulsion of fluid from the splanchnic vascular compartment to the central thoracic compartment. The redistribution of blood volume into the central circulation may lead to a sudden rise in pulmonary and left-sided cardiac pressures in HF. This makes the splanchnic vascular compartment an attractive target in heart failure. Our preliminary proof-of-concept work in patients with acute decompensated and chronic heart failure showed promise for the concept of splanchnic nerve modulation in heart failure. In a series of two small first-in-human studies for acute decompensated heart failure (N=13) (NCT02669407) and chronic heart failure (N=17) (NCT03453151), we found that a splanchnic nerve block (SNB) with lidocaine (90 min duration of action) and ropivacaine (24 hours duration of action) acutely reduced resting and exercise-induced intra-cardiac filling pressures, associated with improved patient symptoms and functional capacity.\n\nThe present study will be a prospective open-label pilot study to help establish feasibility, safety and enable dose finding for botulinumtoxin. Following a baseline invasive (right heart catheterization) cardiopulmonary exercise testing (CPX) patients will undergo unilateral celiac plexus block, followed by repeat hemodynamic testing. Functional testing at baseline and follow up will be supplemented by measures of blood volume and autonomic tone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Followed at DUMC for known or suspected diagnosis of HF (NYHA stage 2-4, Class C-D), including patients on inotropic medication\n* Systolic blood pressure (SBP) \\> 100 mmHg\n* History of HF hospitalization or ER visit or iv diuretic use in last 12 months.\n* Patients will be included regardless of left ventricular ejection fraction.\n\nExclusion Criteria:\n\n* Anticoagulation at the time the procedure or in case of recent warfarin use an INR \\>1.4. Anticoagulation includes: warfarin, or novel oral anticoagulants like dabigatran, rivaroxaban, apixaban, endoxaban or full dose intravenous heparin products or bivalirudin and fondaparinux). Antiplatelet agents besides aspirin such as ticagrelor, prasugrel, Plavix are also considered to be a contraindication if used at time point of procedure.\n* Immunosuppressive medications for solid organ transplant\n* Acute MI (STEMI or Type I NSTEMI) within 7 days?\n* Evidence of progressive cardiogenic shock within 48 hours\n* Restrictive cardiomyopathy\n* Constrictive pericarditis\n* Pericardial effusion with evidence of tamponade\n* Severe valvular stenosis requiring intervention\n* Known history of an increased bleeding risk\n* Thrombocytopenia (\\< 50,000)\n* End-stage renal disease CKD stage 5 due to primary renal pathology'}, 'identificationModule': {'nctId': 'NCT04575428', 'briefTitle': 'Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Splanchnic Nerve Block for Therapy of Chronic Heart Failure (Splanchnic III)', 'orgStudyIdInfo': {'id': 'Pro00103788'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Splanchnic nerve block', 'interventionNames': ['Drug: Splanchnic nerve block']}], 'interventions': [{'name': 'Splanchnic nerve block', 'type': 'DRUG', 'description': 'Percutaneous splanchnic nerve block', 'armGroupLabels': ['Splanchnic nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Marat Fudim, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Universtiy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}