Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-31 @ 11:21 AM
Study NCT ID:
NCT03893760
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2019-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Right Ventricular Function in Advanced Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002311', 'term': 'Cardiomyopathy, Dilated'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D000083083', 'term': 'Laminopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2019-03-26', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with altered Right ventriculo/arterial (R-V/A) coupling over PAPm and Pulmonary Hypertension types', 'timeFrame': 'up to 24 weeks', 'description': 'Significant correlations and augmentation over PAPm and Pulmonay Hypertension'}], 'secondaryOutcomes': [{'measure': 'Rate of agreement in Right ventriculo/arterial (R-V/A) coupling assessment', 'timeFrame': 'up to 24 weeks', 'description': 'Two independent physicians, both experts in echocardiography, independently re-examined 40 studies, randomly selected from all the acquired echocardiographic images. In order to test the R-V/A coupling interobserver agreement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart Failure', 'ventricular elastance', 'dilated cardiomyopathy', 'right heart systolic function', 'right ventriculo-arterial coupling'], 'conditions': ['Dilated Cardiomyopathy', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'We examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (RHC) approach for right ventriculo/arterial (R-V/A) coupling assessment in HF patients with dilated cardiomyopathy (D-CMP).', 'detailedDescription': 'This is a single center, retrospective cross-sectional study. In 2016-17, for 6 months, we evaluated for eligibility 81 consecutive D-CMP patients afferent to "Niguarda Great Metropolitan Hospital" for RHC and echocardiography. All participants underwent the exams in the context of heart-transplant or advanced HF evaluation. Inclusion criteria were: 18 years old, given informed consent, D-CMP, New York Heart Association (NYHA) functional class II or III and reduced EF (≤ 35%). On the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. The final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants underwent the exams in the context of heart-transplant or advanced HF evaluation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old\n* Given informed consent\n* D-CMP\n* New York Heart Association (NYHA) functional class II or III\n* Reduced EF (≤ 35%)\n\nExclusion Criteria:\n\n* Missing the inclusion criteria\n* Refused informed consent'}, 'identificationModule': {'nctId': 'NCT03893760', 'briefTitle': 'Assessment of Right Ventricular Function in Advanced Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'ITAB - Institute for Advanced Biomedical Technologies'}, 'officialTitle': 'Assessment of Right Ventricular Function in Advanced Heart Failure: Feasibility and Reliability of Right Ventricular Elastance', 'orgStudyIdInfo': {'id': 'NGCH001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Pulonary Hypertension', 'description': 'the presence of mean pulmonary pressures (PAPm) at the right heart catheterization \\< 25 mmHg', 'interventionNames': ['Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)']}, {'label': 'Postcapillary Pulmonary Hypertension', 'description': 'PAPm ≥ 25 mmHg and postcapillary wedge pressure (PCWP) \\>15 mmHg', 'interventionNames': ['Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)']}, {'label': 'combined postcapillary/precapillary Pulmonary Hypertension', 'description': 'PAPm ≥ 25 mmHg, PAWP \\>15 mmHg and diastolic peak gradient (DPG - diastolic pulmonary pressure - PCWP) ≥7 mmHg and/or pulmonary vascular resistence (PVR) \\>3 WU, where available.', 'interventionNames': ['Diagnostic Test: Ventriculo-arterial coupling assessment (R-V/A)']}], 'interventions': [{'name': 'Ventriculo-arterial coupling assessment (R-V/A)', 'type': 'DIAGNOSTIC_TEST', 'description': 'R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).', 'armGroupLabels': ['No Pulonary Hypertension', 'Postcapillary Pulmonary Hypertension', 'combined postcapillary/precapillary Pulmonary Hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'facility': 'University "G. d\'Annunzio"', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Niguarda Great Metropolitan Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Francesco Bianco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Cardiology - University "G. d\'Annunzio" - Chieti, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ITAB - Institute for Advanced Biomedical Technologies', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Francesco Bianco', 'investigatorAffiliation': 'ITAB - Institute for Advanced Biomedical Technologies'}}}}