Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2026-01-02 @ 4:25 PM
Study NCT ID:
NCT03268135
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heart Failure and Aortic Stenosis Transcriptome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'cardiac tissue and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac tissutal mRNAs signatures', 'timeFrame': 'from Year 1 to Year 3', 'description': 'The mRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}, {'measure': 'Cardiac tissutal miRNAs signatures', 'timeFrame': 'from Year 1 to Year 3', 'description': 'The miRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}, {'measure': 'Cardiac tissutal lncRNAs signatures', 'timeFrame': 'from Year 1 to Year 3', 'description': 'The lncRNAs cardiac tissutal signatures of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}], 'secondaryOutcomes': [{'measure': 'Non end-stage, end-stage heart failure, aortic stenosis mRNAs signatures in plasmas', 'timeFrame': 'from Year 3 to Year 5', 'description': 'The mRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}, {'measure': 'Non end-stage, end-stage heart failure, aortic stenosis miRNAs signatures in plasmas', 'timeFrame': 'from Year 3 to Year 5', 'description': 'The miRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}, {'measure': 'Non end-stage, end-stage heart failure, aortic stenosis lncRNAs signatures in plasmas', 'timeFrame': 'from Year 3 to Year 5', 'description': 'The lncRNAs dysregulated in cardiac tissues will be measured in blood plasma samples of non- and end-stage heart failure patients and of aortic stenosis patients compared to controls'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['miRNA', 'lncRNAs', 'transcriptome', 'heart failure', 'aortic stenosis', 'biomarkers'], 'conditions': ['Heart Failure', 'Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.', 'detailedDescription': 'The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiac surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Non end-stage heart failure\n\n * left ventricle restoration surgery (SVR)\n * End Systolic Volume Index (ESVI) \\>35 ml/m2\n * Ejection Fraction (EF)\\<40%\n * previous transmural anterior myocardial infarction (MI)\n * age: 40-75\n2. End-stage heart failure\n\n * left ventricle assisted device (LVAD) surgery\n * age: 40-75\n * Ejection Fraction (EF) \\<25%\n * End Systolic Volume Index (ESVI)≥60 ml/m2\n3. Aortic Stenosis\n\n * aortic valve replacement\n * intracardial pressure difference \\>40 mmHg\n * septal diameter ≥1.3 cm\n\nExclusion Criteria:\n\n1. Non end-stage heart failure\n\n * End Systolic Volume Index (ESVI)\\<35 ml/m2\n * Ejection Fraction (EF)\\>40%\n * Time from MI unknown\n * Pregnancy\n * Other genetic diseases\n * Neoplasms\n * Collagenopathies\n * Chemo/radiotherapy\n * Prolonged use of corticosteroids\n * Infections\n * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive\n2. End-stage heart failure\n\n * EF\\>25%\n * Time from MI unknown\n * Pregnancy\n * Other genetic diseases\n * Neoplasms\n * Collagenopathies\n * Chemo/radiotherapy\n * Prolonged use of corticosteroids\n * Infections\n * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive\n3. Aortic Stenosis\n\n * coronaropathies\n * Pregnancy\n * Other genetic diseases\n * Neoplasms\n * Collagenopathies\n * Chemo/radiotherapy\n * Prolonged use of corticosteroids\n * Infections\n * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive'}, 'identificationModule': {'nctId': 'NCT03268135', 'acronym': 'RNA-HF-AS', 'briefTitle': 'Heart Failure and Aortic Stenosis Transcriptome', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Policlinico S. Donato'}, 'officialTitle': 'Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis', 'orgStudyIdInfo': {'id': 'RNA-HF-AS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non end-stage heart failure', 'description': 'Measurement of RNAs in non end-stage heart failure patients undergoing to left ventricle reconstruction', 'interventionNames': ['Diagnostic Test: measurement of RNAs']}, {'label': 'End-stage heart failure', 'description': 'Measurement of RNAs in end-stage heart failure patients undergoing to left ventricular assisted device (LVAD)', 'interventionNames': ['Diagnostic Test: measurement of RNAs']}, {'label': 'Aortic Stenosis', 'description': 'Measurement of RNAs in patients affected by cardiac hypertrophy leading to aortic stenosis and requiring cardiac myectomy', 'interventionNames': ['Diagnostic Test: measurement of RNAs']}, {'label': 'Controls', 'description': 'Measurement of RNAs in individuals not affected by cardiovascular diseases', 'interventionNames': ['Diagnostic Test: measurement of RNAs']}], 'interventions': [{'name': 'measurement of RNAs', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['Aortic Stenosis', 'Controls', 'End-stage heart failure', 'Non end-stage heart failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20097', 'city': 'San Donato Milanese', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'FABIO MARTELLI, PhD', 'role': 'CONTACT', 'email': 'fabio.martelli@grupposandonato.it', 'phone': '0252774683'}, {'name': 'LORENZO MENICANTI, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SIMONA GRECO, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'SERENELLA CASTELVECCHIO, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Irccs Policlinico San Donato', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '20132', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele De Bonis, MD, PhD', 'role': 'CONTACT', 'email': 'debonis.michele@hsr.it'}, {'name': 'MICHELE DE BONIS, MD FESC FAHA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Fabio Martelli, Dr', 'role': 'CONTACT', 'email': 'fabio.martelli@grupposandonato.it', 'phone': '+39 02 26437762'}], 'overallOfficials': [{'name': 'Fabio Martelli, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Policlinico S. Donato'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Policlinico S. Donato', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale San Raffaele', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr, PhD, Molecular Cardiology Laboratory Director', 'investigatorFullName': 'Fabio Martelli', 'investigatorAffiliation': 'IRCCS Policlinico S. Donato'}}}}