Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-02-22 @ 1:29 AM
Study NCT ID:
NCT02170961
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'arterial blood samples collected in EDTA tubes and stored in - 20°C envirement for DNA extraction with salting out methods.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality RAAS', 'timeFrame': 'one year', 'description': 'the association between RAAS genes polymorphisms and mortality at one year average'}], 'secondaryOutcomes': [{'measure': 'association between RAAS polymorphism and AHF', 'timeFrame': 'at admission (an average of 1 day)', 'description': 'the association between the diagnosis of AHF (based on clinical, BNP, and echocardiographic finds) and the RAAS genes polymorphism is studied at patient admission for acute dyspnea.'}, {'measure': 'association between MMP polymorphism and AHF', 'timeFrame': 'at admission (average of 1 day)', 'description': 'the association between the diagnosis of AHF (based on clinical, BNP, and echocardiographic finds) and the MMP genes polymorphism is studied at patient admission for acute dyspnea.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute heart failure', 'RAAS', 'MMP3', 'MMP12', 'Polymorphysm'], 'conditions': ['Acute Heart Failure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.urgencemonastir.com', 'label': 'official website'}]}, 'descriptionModule': {'briefSummary': 'this study aim to investigate the:\n\n* association of RAAS polymorphisms and AHF\n* association of MMP 3 and 12 polymorphisms and AHF', 'detailedDescription': 'Heart failure can be defined as a complex clinical syndrome that results from any structural or functional disorder of the heart, with impairment of ability to fill the ventricles or eject blood. The main event of the IC is dyspnea and fatigue, which limit exercise tolerance and induces water retention.\n\nThe renin angiotensin aldosterone system governs the salt and water homeostasis in the body. Renin is a proteolytic enzyme secreted by the juxtaglomerular apparatus of the kidney (area near the glomeruli). Renin has no direct action on the organism, but that is part of the renin-angiotensin system or the renin-angiotensin-aldosterone system is known.\n\nTo date, few published studies have examined the association between the polymorphism AGT M235T \\* and cardiac dysfunction; and available results are contradictory. What is not known yet is the ratio of this polymorphism with the prognosis of heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acute onset dyspnea patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged more than 18 year old.\n* acute non traumatic dyspnea .\n\nExclusion Criteria:\n\n* ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours\n* a history of a heart transplant, pericardial effusion, chest wall deformity suspected of causing dyspnea\n* coma, shock,MV,vasopressor drugs\n* arrhythmia serious and sustained,\n* pace maker\n* severe mitral valve disease,'}, 'identificationModule': {'nctId': 'NCT02170961', 'acronym': 'PRA-MMP', 'briefTitle': 'Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Study of Polymorphisms of Renin Angiotensin Aldosteron Systemv(RAAS) and Matrice Metallo Protesase (MMPs) in Acute Heart Failure (AHF)', 'orgStudyIdInfo': {'id': 'PRA-MMP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute heart failure (AHF)', 'description': 'patients consulting the emergency department for dyspnea. the diagnosis of AHF was based on clinical, biological (BNP) and echocardiographic data.'}, {'label': 'Non acute heart failure (NAHF)', 'description': 'patients consulting the emergency department for dyspnea. the diagnosis of AHF was based on clinical, biological (BNP) and echocardiographic data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Emergency Department Monastir, Tunisia 5000', 'country': 'Tunisia', 'facility': 'Nouira Samir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Nouira Samir, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}