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

University of São Paulo (USP)

Status: Completed

Conditions: Exposure to Pollution; Heart Failure

Treatments: Other: Unfiltered diesel exhaust; Other: Filtered diesel exhaust; Other: Clean air

Study type: Interventional

Funder types: Other

Identifiers

NCT01960920

3439/10/028

2010/50150-0 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

45 participants in 2 patient groups

Healthy Volunteers

Active Comparator group

Description:

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Treatment:

Other: Clean air

Other: Filtered diesel exhaust

Other: Unfiltered diesel exhaust

Heart Failure patients

Experimental group

Description:

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Treatment:

Other: Clean air

Other: Filtered diesel exhaust

Other: Unfiltered diesel exhaust