Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-11 @ 9:56 AM
Study NCT ID:
NCT01960920
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2013-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004780', 'term': 'Environment, Controlled'}], 'ancestors': [{'id': 'D004777', 'term': 'Environment'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2013-10-09', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Function', 'timeFrame': 'six months', 'description': 'Endothelial function assessment is based on an endothelially mediated arterial response at the distal phalanx of a finger, in response to a five-minute occlusion of the brachial artery. Arterial stiffness is assessed by a finger plethysmographic probe.'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability', 'timeFrame': 'six months', 'description': 'Heart rate variability (HRV) analysis attempts to assess cardiac autonomic regulation through quantification of sinus rhythm variability. Heart rate and beat-to-beat intervals are recorded using a frequency counter Polar Electro Oy - 800 model, interfaced to a microcomputer, and assessed using standard time domain analysis.'}, {'measure': 'Inflammatory Markers', 'timeFrame': '12 months', 'description': 'After each exposure, we collected blood samples for inflammatory variables-including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines.'}, {'measure': 'Six-minute walking test', 'timeFrame': 'Six months', 'description': 'Exercise testing is performed on a treadmill using a modified Naughton protocol and the 6 minute walk test. Ventilation, oxygen uptake, and carbon dioxide production are monitored continuously using a respiratory mass spectrometer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Air Pollution', 'Heart Failure', 'Endothelium', 'Autonomic Dysfunction', 'Cardiopulmonary Exercise Test'], 'conditions': ['Exposure to Pollution', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '26738952', 'type': 'DERIVED', 'citation': 'Vieira JL, Guimaraes GV, de Andre PA, Cruz FD, Saldiva PH, Bocchi EA. Respiratory Filter Reduces the Cardiovascular Effects Associated With Diesel Exhaust Exposure: A Randomized, Prospective, Double-Blind, Controlled Study of Heart Failure: The FILTER-HF Trial. JACC Heart Fail. 2016 Jan;4(1):55-64. doi: 10.1016/j.jchf.2015.07.018.'}]}, 'descriptionModule': {'briefSummary': 'Exposure to air pollution is associated with increase in cardiovascular morbidity and mortality. Controlled human exposure studies have demonstrated impaired vascular function and heart rate variability on healthy volunteers. The aim of this study is to investigate the effects of reducting diesel exhaust inhalation on endothelial function, heart rate variability and cardiopulmonary stress testing in healthy volunteers and patients with chronic heart failure, by using a filter mask.', 'detailedDescription': 'Design and setting: Double-blind randomised crossover studies in a university teaching hospital\n\nPatients: 30 patients with stable Heart Failure (NYHA I-III) and 15 healthy volunteers\n\nInterventions: All 45 subjects will be exposed to dilute diesel exhaust (PM2.5 of 300 mg/m3), filtered diesel exhaust (filter mask), or filtered air\n\nMain outcome measures: Endothelial function, heart rate variability, six-minute walking test and blood samples for inflammatory factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NYHA I-III;\n* Left Ventricle Ejection Fraction \\< 50%;\n* Clinical condition stable for more than three months prior to the randomization;\n\nExclusion Criteria:\n\n* Severe arterial hypertension;\n* Severe Pulmonary disease;\n* Patients with pace-markers;\n* Patients with constrictive pericarditis;\n* Severe chronic kidney disease;\n* Patients with pulmonary hypertension;\n* Stroke within the last six months;\n* Severe hepatic disease;\n* Patients with musculoskeletal limitations to exercise;\n* Patients with cardiac cachexia.'}, 'identificationModule': {'nctId': 'NCT01960920', 'briefTitle': 'Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'InCor Heart Institute'}, 'officialTitle': 'Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial', 'orgStudyIdInfo': {'id': '3439/10/028'}, 'secondaryIdInfos': [{'id': '2010/50150-0', 'type': 'OTHER_GRANT', 'domain': 'FAPESP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers', 'description': 'Dilute diesel exhaust Filtered diesel exhaust Filtered air', 'interventionNames': ['Other: Filtered diesel exhaust', 'Other: Unfiltered diesel exhaust', 'Other: Clean air']}, {'type': 'EXPERIMENTAL', 'label': 'Heart Failure patients', 'description': 'Dilute diesel exhaust Filtered diesel exhaust Filtered air', 'interventionNames': ['Other: Filtered diesel exhaust', 'Other: Unfiltered diesel exhaust', 'Other: Clean air']}], 'interventions': [{'name': 'Filtered diesel exhaust', 'type': 'OTHER', 'otherNames': ['Filter Mask 8812 (www.3m.com.br)'], 'description': 'Mask-filtered exposure to diesel exhaust', 'armGroupLabels': ['Healthy Volunteers', 'Heart Failure patients']}, {'name': 'Unfiltered diesel exhaust', 'type': 'OTHER', 'otherNames': ['Diesel Generator Toyama TD-2500 C, www.toyama.com.br'], 'description': 'Diesel Exhaust Inhalation', 'armGroupLabels': ['Healthy Volunteers', 'Heart Failure patients']}, {'name': 'Clean air', 'type': 'OTHER', 'description': 'No pollution and no filter mask', 'armGroupLabels': ['Healthy Volunteers', 'Heart Failure patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Heart Failure Lab. Incor HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Edimar A Bocchi, pHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Failure Lab. Coordinator'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InCor Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}, {'name': 'LABORATÓRIO DE INSUFICIÊNCIA CARDÍACA E TRANSPLANTE INCOR/HCFMUSP', 'class': 'UNKNOWN'}, {'name': 'LABORATÓRIO DE POLUIÇÃO ATMOSFÉRICA EXPERIMENTAL (LPAE/ FMUSP).', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jefferson Luis Vieira', 'investigatorAffiliation': 'InCor Heart Institute'}}}}