Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT00143793
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['natruretic peptides', 'NT-proBNP', 'new biomarkers', 'congestive heart failure', 'atrial fibrillation', 'acute myocardial infarction', 'lung embolism'], 'conditions': ['Dyspnea', 'Peripheral Edema']}, 'referencesModule': {'references': [{'pmid': '26072112', 'type': 'DERIVED', 'citation': 'Hoffmann U, Espeter F, Weiss C, Ahmad-Nejad P, Lang S, Brueckmann M, Akin I, Neumaier M, Borggrefe M, Behnes M. Ischemic biomarker heart-type fatty acid binding protein (hFABP) in acute heart failure - diagnostic and prognostic insights compared to NT-proBNP and troponin I. BMC Cardiovasc Disord. 2015 Jun 14;15:50. doi: 10.1186/s12872-015-0026-0.'}, {'pmid': '24146089', 'type': 'DERIVED', 'citation': 'Behnes M, Brueckmann M, Lang S, Weiss C, Ahmad-Nejad P, Neumaier M, Borggrefe M, Hoffmann U. Connective tissue growth factor (CTGF/CCN2): diagnostic and prognostic value in acute heart failure. Clin Res Cardiol. 2014 Feb;103(2):107-16. doi: 10.1007/s00392-013-0626-6. Epub 2013 Oct 22.'}, {'pmid': '23851388', 'type': 'DERIVED', 'citation': 'Behnes M, Brueckmann M, Lang S, Espeter F, Weiss C, Neumaier M, Ahmad-Nejad P, Borggrefe M, Hoffmann U. Diagnostic and prognostic value of osteopontin in patients with acute congestive heart failure. Eur J Heart Fail. 2013 Dec;15(12):1390-400. doi: 10.1093/eurjhf/hft112. Epub 2013 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to:\n\n* Evaluate the sensitivity and specificity of NT-proBNP (N-terminal prohormone brain natriuretic peptide) and new biomarker measurements for the diagnosis of heart failure in patients with acute dyspnea and/or edema.\n* Determine the exact biomarker cut-off point(s) for the differentiation of healthy persons, patients with heart failure and patients with dyspnea of other origin.\n* Evaluate treatment costs in patients with dyspnea under special consideration of NT-proBNP measurement.', 'detailedDescription': 'Primary endpoint:\n\n* Sensitivity and specificity of biomarker measurements for discrimination of heart failure from dyspnea of other origin.\n\nSecondary endpoints:\n\n* Determination of Cut-off(s)\n* Discrimination of cardiac and non-cardiac diseases causing to dyspnea or peripheral edema\n* Determination of treatment costs of the initial hospital stay\n* Evaluation of resource savings when implementing NT-proBNP for determination of diagnosis.\n* Time to diagnosis.\n* Hospitalization rate /Intensive care treatment rate between day 1 and 28\n* Duration of initial hospital stay\n* 30-day re-hospitalization rate\n* 30 day mortality rate and adverse event rate\n* 1 and 5 year mortality rates\n* 1 and 5 year rehospitalization rates'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from dyspnea and peripheral edema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-90 years\n* Dyspnea or/and peripheral edema\n* Informed consent\n\nExclusion Criteria:\n\n* Renal insufficiency with creatinine \\> 2.8mg/dl\n* Anemia (hemoglobin \\< 8.0mg/dl)\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00143793', 'acronym': 'MANPRO', 'briefTitle': 'NT-proBNP and New Biomarkers in Patients With Dyspnea and/or Peripheral Edema', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Mannheim NT-proBNP Study (MANPRO) Evaluating NT-proBNP and New Biomarkers in Patients Suffering From Dyspnea and/or Peripheral Edema for the Differential Diagnosis of Congestive Heart Failure', 'orgStudyIdInfo': {'id': '80/05'}}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Medical Faculty Mannheim, University of Heidelberg', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Martina Brueckmann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Department of Medicine, University Medical Centre Mannheim'}, {'name': 'Martin Borggrefe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Department of Medicine, University Medical Centre Mannheim'}, {'name': 'Michael Neumaier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Clinical Chemistry, University Medical Centre Mannheim'}, {'name': 'Parviz Ahmad-Nejad, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Clinical Chemistry, University Medical Centre Mannheim'}, {'name': 'Michael Behnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Department of Medicine, University Medical Centre Mannheim'}, {'name': 'Ursula Hoffmann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Department of Medicine, University Medical Centre Mannheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Michael Behnes', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}