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

This study has been completed.
Sponsor:
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).
Information provided by (Responsible Party):
Jefferson Luis Vieira, InCor Heart Institute
ClinicalTrials.gov Identifier:
NCT01960920
First received: October 9, 2013
Last updated: August 24, 2015
Last verified: August 2015

October 9, 2013
August 24, 2015
February 2013
June 2014   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: six months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01960920 on ClinicalTrials.gov Archive Site
  • Heart rate variability [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    After each exposure, we collected blood samples for inflammatory variables—including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines.
  • Six-minute walking test [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    After each exposure, we collected blood samples for inflammatory variables—including circulating leukocytes, serum C-reactive protein, B-type natriuretic peptide, Troponin and Catecholamines.
  • Cardiopulmonary Stress Testing [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
 
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Exposure to Pollution
  • Heart Failure
  • Other: Filtered diesel exhaust
    Mask-filtered exposure to diesel exhaust
    Other Name: Filter Mask 8812 (www.3m.com.br)
  • Other: Unfiltered diesel exhaust
    Diesel Exhaust Inhalation
    Other Name: Diesel Generator Toyama TD-2500 C, www.toyama.com.br
  • Other: Clean air
    No pollution and no filter mask
  • Active Comparator: Healthy Volunteers
    Dilute diesel exhaust Filtered diesel exhaust Filtered air
    Interventions:
    • Other: Filtered diesel exhaust
    • Other: Unfiltered diesel exhaust
    • Other: Clean air
  • Experimental: Heart Failure patients
    Dilute diesel exhaust Filtered diesel exhaust Filtered air
    Interventions:
    • Other: Filtered diesel exhaust
    • Other: Unfiltered diesel exhaust
    • Other: Clean air
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
January 2015
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01960920
3439/10/028, 2010/50150-0
No
Not Provided
Not Provided
Jefferson Luis Vieira, InCor Heart Institute
InCor Heart Institute
  • 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).
Study Chair: Edimar A Bocchi, pHD Heart Failure Lab. Coordinator
InCor Heart Institute
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP