Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-02 @ 8:50 AM
Study NCT ID:
NCT02064218
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emerging Biomarkers in Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000959', 'term': 'Antihypertensive Agents'}], 'ancestors': [{'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'lastUpdateSubmitDate': '2014-02-13', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-13', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of vascular stiffness', 'timeFrame': '5 years', 'description': '\\- Aortic Pulse Wave velocity (PWV)'}], 'primaryOutcomes': [{'measure': 'Blood pressure reduction', 'timeFrame': '5 years', 'description': '* Systolic Blood Pressure (SBP)\n* Diastolic Blood Pressure (DBP)'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular and metabolic biomarkers', 'timeFrame': '5 years', 'description': '* Lipoprotein (a) (Lp(a))\n* sRAGE (soluble Receptor for Advanced Glycation End-products)\n* sCD40L (soluble ligand of CD40)\n* MPO (myeloperoxidase)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '27068332', 'type': 'DERIVED', 'citation': "Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Barnidipine compared to lercanidipine in addition to losartan on endothelial damage and oxidative stress parameters in patients with hypertension and type 2 diabetes mellitus. BMC Cardiovasc Disord. 2016 Apr 12;16:66. doi: 10.1186/s12872-016-0237-z."}, {'pmid': '26407654', 'type': 'DERIVED', 'citation': "Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. Perindopril and barnidipine alone or combined with simvastatin on hepatic steatosis and inflammatory parameters in hypertensive patients. Eur J Pharmacol. 2015 Nov 5;766:31-6. doi: 10.1016/j.ejphar.2015.09.030. Epub 2015 Sep 25."}, {'pmid': '26243165', 'type': 'DERIVED', 'citation': "Derosa G, Mugellini A, Querci F, Franzetti I, Pesce RM, D'Angelo A, Maffioli P. Barnidipine or Lercanidipine on Echocardiographic Parameters in Hypertensive, Type 2 Diabetics with Left Ventricular Hypertrophy: A Randomized Clinical Trial. Sci Rep. 2015 Aug 5;5:12603. doi: 10.1038/srep12603."}, {'pmid': '26223257', 'type': 'DERIVED', 'citation': "Derosa G, Mugellini A, Pesce RM, D'Angelo A, Maffioli P. A study about the relevance of adding acetylsalicylic acid in primary prevention in subjects with type 2 diabetes mellitus: effects on some new emerging biomarkers of cardiovascular risk. Cardiovasc Diabetol. 2015 Jul 30;14:95. doi: 10.1186/s12933-015-0254-8."}, {'pmid': '25319120', 'type': 'DERIVED', 'citation': "Derosa G, Romano D, Bianchi L, D'Angelo A, Maffioli P. The effects of canrenone on inflammatory markers in patients with metabolic syndrome. Ann Med. 2015 Feb;47(1):47-52. doi: 10.3109/07853890.2014.969303. Epub 2014 Oct 16."}]}, 'descriptionModule': {'briefSummary': 'First of all to evaluate the relationship between non-conventional biomarkers and essential hypertension; then to evaluate the effects of various anti-hypertensive drugs on blood pressure control and non-conventional biomarkers in naive hypertensive patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with naive essential hypertension aged \\< 65 years without previous cardiovascular events', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* essential hypertension\n* naive to treatment\n* \\< 65 years\n\nExclusion Criteria:\n\n* secondary hypertension\n* previous cardiovascular events'}, 'identificationModule': {'nctId': 'NCT02064218', 'briefTitle': 'Emerging Biomarkers in Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Evaluation of Some Emerging Biomarkers of Cardiovascular Risk Stratification in Hypertensive Patients: a 5-years Follow-up', 'orgStudyIdInfo': {'id': '20070002649'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hypertensive patients', 'description': 'Hypertensive patients naive to hypertensive treatment', 'interventionNames': ['Drug: Anti-hypertensive drugs']}, {'label': 'healthy subjects', 'description': 'healthy subjects'}], 'interventions': [{'name': 'Anti-hypertensive drugs', 'type': 'DRUG', 'armGroupLabels': ['Hypertensive patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it', 'phone': '+39 0382 502614'}, {'name': 'Pamela Maffioli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico S.Matteo Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it', 'phone': '+39 0382 502614'}, {'name': 'Amedeo Mugellini, MD, PhD', 'role': 'CONTACT', 'email': 'amedeo.mugellini@unipv.it', 'phone': '+39 0382 502614'}], 'overallOfficials': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pavia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}