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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-01-31

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.

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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

Conditions

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Exposure to Pollution Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Healthy Volunteers

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Group Type ACTIVE_COMPARATOR

Filtered diesel exhaust

Intervention Type OTHER

Mask-filtered exposure to diesel exhaust

Unfiltered diesel exhaust

Intervention Type OTHER

Diesel Exhaust Inhalation

Clean air

Intervention Type OTHER

No pollution and no filter mask

Heart Failure patients

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Group Type EXPERIMENTAL

Filtered diesel exhaust

Intervention Type OTHER

Mask-filtered exposure to diesel exhaust

Unfiltered diesel exhaust

Intervention Type OTHER

Diesel Exhaust Inhalation

Clean air

Intervention Type OTHER

No pollution and no filter mask

Interventions

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Filtered diesel exhaust

Mask-filtered exposure to diesel exhaust

Intervention Type OTHER

Unfiltered diesel exhaust

Diesel Exhaust Inhalation

Intervention Type OTHER

Clean air

No pollution and no filter mask

Intervention Type OTHER

Other Intervention Names

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Filter Mask 8812 (www.3m.com.br) Diesel Generator Toyama TD-2500 C, www.toyama.com.br

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes