Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT01738659
Status:
COMPLETED
Last Update Posted:
2012-11-30
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimated Echocardiographic Pulmonary Capillary Wedge Pressure 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2012-10-23', 'studyFirstSubmitQcDate': '2012-11-27', 'lastUpdatePostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of hospital readmitted patients', 'timeFrame': '1 year', 'description': 'every six months we measure the PCWP by echocardiography'}], 'secondaryOutcomes': [{'measure': 'number of death', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sodium ,diuretics, PCWP'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to verify the effects of moderate versus low sodium intake on pulmonary capillary wedge pressure (PCWP), determined by Doppler echocardiography and tissue Doppler imaging in patients suffering from compensated heart failure.', 'detailedDescription': 'the study outcome is hospital readmission and mortality after 12 months of two different sodium diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* compensated HF patients\n\nExclusion Criteria:\n\n* decompensated HF patients'}, 'identificationModule': {'nctId': 'NCT01738659', 'briefTitle': 'Estimated Echocardiographic Pulmonary Capillary Wedge Pressure in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Moderate Versus Low Sodium Diet Intake Effects on Estimated Echocardiographic Pulmonary Capillary Wedge Pressure During 12 Months of Follow up in Compensated Heart Failure Patients.', 'orgStudyIdInfo': {'id': 'UNIPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'normal sodium diet (120 mmol/die)', 'description': 'active comparator: low sodium diet (80 mmol/die)', 'interventionNames': ['Dietary Supplement: normal sodium diet']}], 'interventions': [{'name': 'normal sodium diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'normal sodium diet (120 mmol/daily) for 1 year', 'armGroupLabels': ['normal sodium diet (120 mmol/die)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'pietro di pasquale, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'G.F. Ingrassia Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale G. F. Ingrassia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Gaspare Parrinello', 'investigatorAffiliation': 'University of Palermo'}}}}