Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial

Conditions
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Exposure to Pollution, Heart Failure

Intervention / Treatment
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* Other: Filtered diesel exhaust
* Other: Unfiltered diesel exhaust
* Other: Clean air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NYHA I-III; Left Ventricle Ejection Fraction < 50%; Clinical condition stable for more than three months prior to the randomization; Exclusion Criteria: Severe arterial hypertension; Severe Pulmonary disease; Patients with pace-markers; Patients with constrictive pericarditis; Severe chronic kidney disease; Patients with pulmonary hypertension; Stroke within the last six months; Severe hepatic disease; Patients with musculoskeletal limitations to exercise; Patients with cardiac cachexia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy Volunteers<br>Dilute diesel exhaust Filtered diesel exhaust Filtered air | Other: Filtered diesel exhaust<br>* Mask-filtered exposure to diesel exhaust<br>* Other names: Filter Mask 8812 (www.3m.com.br);Other: Unfiltered diesel exhaust<br>* Diesel Exhaust Inhalation<br>* Other names: Diesel Generator Toyama TD-2500 C, www.toyama.com.br;Other: Clean air<br>* No pollution and no filter mask<br>|
| Experimental: Heart Failure patients<br>Dilute diesel exhaust Filtered diesel exhaust Filtered air | Other: Filtered diesel exhaust<br>* Mask-filtered exposure to diesel exhaust<br>* Other names: Filter Mask 8812 (www.3m.com.br);Other: Unfiltered diesel exhaust<br>* Diesel Exhaust Inhalation<br>* Other names: Diesel Generator Toyama TD-2500 C, www.toyama.com.br;Other: Clean air<br>* No pollution and no filter mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air Pollution, Heart Failure, Endothelium, Autonomic Dysfunction, Cardiopulmonary Exercise Test