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

N/ACompletedNCT01960920

InCor Heart Institute45 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Exposure to Pollution Heart Failure

Interventions

Filtered diesel exhaustOTHER

Mask-filtered exposure to diesel exhaust

Unfiltered diesel exhaustOTHER

Diesel Exhaust Inhalation

Clean airOTHER

No pollution and no filter mask

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Heart Failure Lab. Incor HCFMUSP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: six months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Six months

Data from ClinicalTrials.gov

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