Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05439369
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2022-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early detection of subclinical LV dysfunction.', 'timeFrame': '1 year', 'description': 'early detection of subclinical LV dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease Stenosis and Regurgitation']}, 'descriptionModule': {'briefSummary': 'NPs can be used To detect subset of asymptomatic with subtle LV dysfunction for further evaluation and earlier referral for intervention and its correlation with echocardiographic finding.', 'detailedDescription': 'Each patient included in the study will undergo:\n\n1. History taking:\n\n Analysis of patient symptoms and signs (dyspnea , orthopnea , Paroxysmal nocturnal dyspnea, lower limb edema , tachypalpitations,…etc )\n2. Clinical examination:\n\n * Detecion of each patient body weight , height , calculation of BMI.\n * General examination for detection of signs of Heart failure (raised JVP , lower limb edema, ..etc)\n * Examination to respiratory system\n * Auscultation of the heart for detection of valvular affection before echocardiography\n\nInvesigations:\n\nLaboratory investigations:\n\nUrea and creatinine . b) ECG : for exclusion of atrial fibrillation and other arrythmias. 2D Transthorathic Echocardiography (TTE) Evaluation of valve morphology and thickness , gradients and valve area , regurgitant lesions and its severity.\n\nEvaluation of internal cardiac dimensions and function. 5- Natriuretic peptides: as a useful screening tool to differentiate symptomatic and asymptomatic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'the study will include consecutive eligible patients recruited in assiut university hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients echocardiographically diagnosed with significant valve lesions. Rheumatic Heart disease with significant but asymptomatic valvular Heart Disease especially (Mitral valve disease )(MS and MR) Gender: male \\& female\n\nExclusion Criteria:\n\n* Cases with increased level of BNP as in :\n\nRenal impairment Advanced age and obesity Atrial fibrillation and acute coronary syndromes Prior lung diseases and acute illness'}, 'identificationModule': {'nctId': 'NCT05439369', 'briefTitle': 'Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Natriuretic Peptides as a Prognostic and Risk Stratification Tool in Assessment of Valvular Heart Disease', 'orgStudyIdInfo': {'id': 'NPs in Valvular heart diseases'}}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Assiut University ,faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Muhammad KE thabet, resident', 'role': 'CONTACT', 'email': 'muhammadkhidr147@gmail.com', 'phone': '01150713889'}, {'name': 'Amr Ahmed Aly Yousif, Professor', 'role': 'CONTACT', 'email': 'Amryoussef111@yahoo.com', 'phone': '01027355511'}], 'overallOfficials': [{'name': 'Mohamed Aly Abdelhafez, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Doctor', 'investigatorFullName': 'Muhammad Khidr Ezzat thabet', 'investigatorAffiliation': 'Assiut University'}}}}