NCT01960920

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: InCor Heart Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Exposure to Pollution
• Heart Failure

Interventions

Type	Name	Description
OTHER	Filtered diesel exhaust	Mask-filtered exposure to diesel exhaust
OTHER	Unfiltered diesel exhaust	Diesel Exhaust Inhalation
OTHER	Clean air	No pollution and no filter mask

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-06-01
• Completion: 2015-01-01
• First posted: 2013-10-11
• Last updated: 2015-08-25

Locations

1 site across 1 country: Brazil