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

Not Applicable

Completed

• Conditions: Exposure to Pollution; Heart Failure
• Interventions: Other: Filtered diesel exhaust; Other: Unfiltered diesel exhaust; Other: Clean air

• Registration Number: NCT01960920
• Lead Sponsor: InCor Heart Institute

Brief 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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-10-09
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Primary Completion: 2014-06
• Study Completion: 2015-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Filtered diesel exhaust	Dilute diesel exhaust Filtered diesel exhaust Filtered air
Heart Failure patients	Clean air	Dilute diesel exhaust Filtered diesel exhaust Filtered air
Healthy Volunteers	Unfiltered diesel exhaust	Dilute diesel exhaust Filtered diesel exhaust Filtered air
Heart Failure patients	Filtered diesel exhaust	Dilute diesel exhaust Filtered diesel exhaust Filtered air
Healthy Volunteers	Clean air	Dilute diesel exhaust Filtered diesel exhaust Filtered air
Heart Failure patients	Unfiltered diesel exhaust	Dilute diesel exhaust Filtered diesel exhaust Filtered air

Primary Outcome Measures

Name	Time	Method
Endothelial Function	six months	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.

Secondary Outcome Measures

Name	Time	Method
Six-minute walking test	Six months	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.
Heart rate variability	six months	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.
Inflammatory Markers	12 months	After each exposure, we collected blood samples for inflammatory variables-including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines.

Trial Locations

Locations (1)

Heart Failure Lab. Incor HCFMUSP; 🇧🇷 São Paulo, Brazil