Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT01023451
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2009-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of Brain Natriuretic Peptide (BNP) levels to elevated Tricuspid Regurgitation Flow Velocity (TRV)', 'timeFrame': 'one day', 'description': 'Subjects will be asked to participate in the study by allowing a review of their echocardiographic findings. In addition, they will be asked for a 1 ml blood sample during routine annual follow ups for BNP levels to be drawn.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary hypertension', 'Sickle cell disease', 'Pediatric patients', 'Brain Natriuretic Peptide levels'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '14985486', 'type': 'BACKGROUND', 'citation': 'Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients with sickle cell disease. N Engl J Med. 2004 Feb 26;350(9):886-95. doi: 10.1056/NEJMoa035477.'}, {'pmid': '15501204', 'type': 'BACKGROUND', 'citation': 'Ataga KI, Sood N, De Gent G, Kelly E, Henderson AG, Jones S, Strayhorn D, Lail A, Lieff S, Orringer EP. Pulmonary hypertension in sickle cell disease. Am J Med. 2004 Nov 1;117(9):665-9. doi: 10.1016/j.amjmed.2004.03.034.'}, {'pmid': '16344670', 'type': 'BACKGROUND', 'citation': 'Suell MN, Bezold LI, Okcu MF, Mahoney DH Jr, Shardonofsky F, Mueller BU. Increased pulmonary artery pressures among adolescents with sickle cell disease. J Pediatr Hematol Oncol. 2005 Dec;27(12):654-8. doi: 10.1097/01.mph.0000194022.17968.bf.'}, {'pmid': '17483714', 'type': 'BACKGROUND', 'citation': 'Nelson SC, Adade BB, McDonough EA, Moquist KL, Hennessy JM. High prevalence of pulmonary hypertension in children with sickle cell disease. J Pediatr Hematol Oncol. 2007 May;29(5):334-7. doi: 10.1097/MPH.0b013e31805d8f32.'}, {'pmid': '12393669', 'type': 'BACKGROUND', 'citation': 'Castro O, Hoque M, Brown BD. Pulmonary hypertension in sickle cell disease: cardiac catheterization results and survival. Blood. 2003 Feb 15;101(4):1257-61. doi: 10.1182/blood-2002-03-0948. Epub 2002 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is\n\n1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid regurgitation flow velocity levels in pediatric patients with sickle cell disease\n2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain natriuretic peptide levels and pulmonary hypertension', 'detailedDescription': 'Pulmonary hypertension is recognized as a significant cause of morbidity and mortality in patients with sickle cell disease. Doppler echocardiography is a recommended noninvasive screening tool for sickle cell disease patients with pulmonary hypertension. Brain natriuretic peptide levels have been found to be a possible serum screening marker. This research will offer the opportunity to determine if there is any possible relationship between magnitude of BNP concentration and degree of TRV, if it can be used as a screening test in SCD pediatric patients with PHT and form the basis for a future multicenter study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sickle cell clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female any age\n* Diagnosis of SCD with PHT on echocardiogram\n* Controls must have a diagnosis of sickle cell disease without Pulmonary hypertension, age, gender and disease type match to subjects with pulmonary hypertension\n* Parent or Legal guardian willing to sign informed consent form\n\nExclusion Criteria:\n\n* Abnormal echocardiograms not related to PHT\n* Parent or Legal guardian unwilling or unable to give written informed consent'}, 'identificationModule': {'nctId': 'NCT01023451', 'briefTitle': 'Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients', 'organization': {'class': 'OTHER', 'fullName': "Akron Children's Hospital"}, 'officialTitle': 'Serum Brain Natriuretic Peptide Levels and Its Correlation With Echocardiographic Measurements Suggestive of Pulmonary Hypertension in Pediatric Patients With Sickle Cell Disease', 'orgStudyIdInfo': {'id': '091007'}}, 'contactsLocationsModule': {'locations': [{'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital Sickle Cell Clinic", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Stephanie Do, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Akron Children's Hospital"}, {'name': 'Jeffrey Hord, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Akron Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Akron Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}