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Completed

NCT Number: NCT01960920

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

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.

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Key information

Conditions

Exposure to Pollution Autonomic Nervous System Diseases Cardiovascular Diseases Heart Diseases Heart Failure Nervous System Diseases Primary Dysautonomias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Failure Lab. Incor HCFMUSP

São Paulo, 05403900, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filtered diesel exhaust

Other

Mask-filtered exposure to diesel exhaust

Other names: Filter Mask 8812 (www.3m.com.br)

Unfiltered diesel exhaust

Other

Diesel Exhaust Inhalation

Other names: Diesel Generator Toyama TD-2500 C, www.toyama.com.br

Clean air

Other

No pollution and no filter mask

Primary outcomes

  1. Endothelial Function

    Time frame: 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 outcomes

  1. Heart rate variability

    Time frame: 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.

  2. Inflammatory Markers

    Time frame: 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.

  3. Six-minute walking test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

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).

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 11, 2013
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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