Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT05836233
Status:
UNKNOWN
Last Update Posted:
2023-05-01
First Post:
2023-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint', 'timeFrame': '18 months', 'description': 'Early right heart failure'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint', 'timeFrame': '24 months', 'description': 'In-hospital all-cause mortality'}, {'measure': 'Secondary Endpoint', 'timeFrame': '24 months', 'description': '1-year all-cause mortality;'}, {'measure': 'Secondary Endpoint', 'timeFrame': '24 months', 'description': 'Late right heart failure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LVAD', 'Right Heart Failure', 'Advanced Heart Failure', 'Nitroprusside', 'Right Heart Catheterization'], 'conditions': ['Right Heart Failure']}, 'referencesModule': {'references': [{'pmid': '32386998', 'type': 'RESULT', 'citation': 'Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.\n\nLVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol.\n\nThereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.', 'detailedDescription': "Inclusion criteria\n\n* Age over 18 years old.\n* Diagnosis of advanced heart failure with an indication for LVAD implantation.\n* Mean Arterial Pressure (MAP) \\> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \\> 20 mmHg; Pulmonary Artery Wedge Pressure \\>15 mmHg.\n* Vasodilator Challenge performed through NTP infusion.\n\nExclusion criteria\n\n* State of pregnancy.\n* Inability to perform vasodilator challenge\n* Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.\n* Planned right ventricular assist device implantation in the peri-procedural setting.\n\nRight heart catheterization (RHC) RHC will be performed under optimal medical therapy within 90 days before LVAD implantation.\n\nVasodilator challenge will be performed through intravenous nitroprusside administration and titration (by 5 minutes intervals) until symptoms (flushing or hypotension) onset or systolic systemic pressure drops below 85 mmHg.\n\nDobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion.\n\nAll haemodynamic measurements will be repeated after nitroprusside infusion and titration.\n\nRight heart failure (RHF) Post-operative RHF will be evaluated according to the definition proposed by the 2020 consensus statement of the mechanical circulatory support academic research consortium (1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced heart failure patients undergoing left ventricular assist device implantation in our centers satisfying the inclusion criteria.\n\nAll patients presenting one or more of the exclusion criteria will not be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age over 18 years old.\n* Diagnosis of advanced heart failure with an indication for LVAD implantation.\n* Mean Arterial Pressure (MAP) \\> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \\> 20 mmHg; Pulmonary Artery Wedge Pressure \\>15 mmHg.\n* Vasodilator Challenge performed through NTP infusion.\n\nExclusion criteria\n\n* State of pregnancy.\n* Inability to perform vasodilator challenge\n* Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.\n* Planned right ventricular assist device implantation in the peri-procedural setting.'}, 'identificationModule': {'nctId': 'NCT05836233', 'acronym': 'PREVV-RHF-LVAD', 'briefTitle': 'Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation', 'organization': {'class': 'OTHER', 'fullName': 'San Camillo Hospital, Rome'}, 'officialTitle': 'Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation', 'orgStudyIdInfo': {'id': '1235/CE Lazio 1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled patients - LVAD candidates', 'description': 'Inclusion criteria\n\n* Age over 18 years old.\n* Diagnosis of advanced heart failure with an indication for LVAD implantation.\n* Mean Arterial Pressure (MAP) \\> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \\> 20 mmHg; Pulmonary Artery Wedge Pressure \\>15 mmHg.\n* Vasodilator Challenge performed through NTP infusion.\n\nExclusion criteria\n\n* State of pregnancy.\n* Inability to perform vasodilator challenge\n* Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.\n* Planned right ventricular assist device implantation in the peri-procedural setting.', 'interventionNames': ['Drug: Pulmonary Vasodilators']}], 'interventions': [{'name': 'Pulmonary Vasodilators', 'type': 'DRUG', 'otherNames': ['Vasodilator Challenge'], 'description': "Right heart catheterization via Swan Ganz catether will be performed under optimal medical therapy within 90 days before LVAD implantation. We will record the timing between RHC and LVAD implantation.\n\nVasodilator challenge will be performed through intravenous nitroprusside administration and titration (by 5 minutes intervals) until symptoms (flushing or hypotension) onset or systolic systemic pressure drop below 85 mmHg (target dose).\n\nDobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion.\n\nAll haemodynamic measurements will be repeated after nitroprusside infusion and titration until the target dose.", 'armGroupLabels': ['Enrolled patients - LVAD candidates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00152', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giulio Cacioli, MD', 'role': 'CONTACT', 'email': 'giulio.cacioli@gmail.com', 'phone': '+390658704604'}, {'name': 'Fabio Sbaraglia, MD', 'role': 'CONTACT', 'email': 'fsbaraglia@gmail.com', 'phone': '+390658704604'}], 'facility': 'San Camillo Hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Giulio Cacioli, MD', 'role': 'CONTACT', 'email': 'giulio.cacioli@gmail.com', 'phone': '+3906 58704604'}, {'name': 'Fabio Sbaraglia, MD', 'role': 'CONTACT', 'email': 'fsbaraglia@gmail.com', 'phone': '+3906 58704604'}], 'overallOfficials': [{'name': 'Francesco Musumeci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Camillo Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Camillo Hospital, Rome', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Giulio Cacioli', 'investigatorAffiliation': 'San Camillo Hospital, Rome'}}}}