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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Exposure to Pollution
• Intervention / Treatment: Other: Filtered diesel exhaust; Other: Unfiltered diesel exhaust; Other: Clean air

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05403900
    • Heart Failure Lab. Incor HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy Volunteers; Dilute diesel exhaust Filtered diesel exhaust Filtered air	Other: Filtered diesel exhaust; Mask-filtered exposure to diesel exhaust; Other Names: Filter Mask 8812 (www.3m.com.br); Other: Unfiltered diesel exhaust; Diesel Exhaust Inhalation; Other Names: Diesel Generator Toyama TD-2500 C, www.toyama.com.br; Other: Clean air; No pollution and no filter mask
Experimental: Heart Failure patients; Dilute diesel exhaust Filtered diesel exhaust Filtered air	Other: Filtered diesel exhaust; Mask-filtered exposure to diesel exhaust; Other Names: Filter Mask 8812 (www.3m.com.br); Other: Unfiltered diesel exhaust; Diesel Exhaust Inhalation; Other Names: Diesel Generator Toyama TD-2500 C, www.toyama.com.br; Other: Clean air; No pollution and no filter mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Six months

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; LABORATÓRIO DE INSUFICIÊNCIA CARDÍACA E TRANSPLANTE INCOR/HCFMUSP; LABORATÓRIO DE POLUIÇÃO ATMOSFÉRICA EXPERIMENTAL (LPAE/ FMUSP).
• Investigators: Study Chair: Edimar A Bocchi, pHD, Heart Failure Lab. Coordinator

Publications and helpful links

General Publications

• Vieira JL, Guimaraes GV, de Andre PA, Cruz FD, Saldiva PH, Bocchi EA. Respiratory Filter Reduces the Cardiovascular Effects Associated With Diesel Exhaust Exposure: A Randomized, Prospective, Double-Blind, Controlled Study of Heart Failure: The FILTER-HF Trial. JACC Heart Fail. 2016 Jan;4(1):55-64. doi: 10.1016/j.jchf.2015.07.018.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 9, 2013
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Estimate): August 25, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Air Pollution; Cardiopulmonary Exercise Test; Endothelium; Autonomic Dysfunction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 3439/10/028; 2010/50150-0 (Other Grant/Funding Number: FAPESP)