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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/50150-0 | Other Grant/Funding Number | FAPESP |
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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| LABORATÓRIO DE INSUFICIÊNCIA CARDÍACA E TRANSPLANTE INCOR/HCFMUSP | UNKNOWN |
| LABORATÓRIO DE POLUIÇÃO ATMOSFÉRICA EXPERIMENTAL (LPAE/ FMUSP). |
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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.
Design and setting: Double-blind randomised crossover studies in a university teaching hospital
Patients: 30 patients with stable Heart Failure (NYHA I-III) and 15 healthy volunteers
Interventions: All 45 subjects will be exposed to dilute diesel exhaust (PM2.5 of 300 mg/m3), filtered diesel exhaust (filter mask), or filtered air
Main outcome measures: Endothelial function, heart rate variability, six-minute walking test and blood samples for inflammatory factors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Active Comparator | Dilute diesel exhaust Filtered diesel exhaust Filtered air |
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| Heart Failure patients | Experimental | Dilute diesel exhaust Filtered diesel exhaust Filtered air |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filtered diesel exhaust | Other | Mask-filtered exposure to diesel exhaust |
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| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function | 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. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | 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. | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edimar A Bocchi, pHD | Heart Failure Lab. Coordinator | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Failure Lab. Incor HCFMUSP | São Paulo | São Paulo | 05403900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26738952 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004780 | Environment, Controlled |
| ID | Term |
|---|---|
| D004777 | Environment |
| D004778 | Environment and Public Health |
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| Unfiltered diesel exhaust | Other | Diesel Exhaust Inhalation |
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| Clean air | Other | No pollution and no filter mask |
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| Inflammatory Markers | After each exposure, we collected blood samples for inflammatory variables-including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines. | 12 months |
| Six-minute walking test | 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. | Six months |