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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by InCor Heart Institute
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: NA
Last verified: October 2013
History: No changes posted

October 9, 2013
October 9, 2013
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
No Changes Posted
  • 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.
Same as current
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 10 healthy volunteers

Interventions: All 40 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, cardiopulmonary variables during a 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
    Filter Mask - air pollution reduction
    Other Name: Filter Mask 8812 (www.3m.com.br)
  • Other: Dilute diesel exhaust
    Diesel Exhaust Inhalation
    Other Name: Diesel Generator Toyama TD-2500 C, www.toyama.com.br
  • Other: Filtered 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: Dilute diesel exhaust
    • Other: Filtered air
  • Experimental: Heart Failure patients
    Dilute diesel exhaust Filtered diesel exhaust Filtered air
    Interventions:
    • Other: Filtered diesel exhaust
    • Other: Dilute diesel exhaust
    • Other: Filtered air
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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
Yes
Contact: Jefferson L Vieira, MD 55 (11) 988133085 jefvieira@yahoo.com.br
Contact: Edimar A Bocchi, pHD 55 (11) 997081692 dcledimar@incor.usp.br
Brazil
 
NCT01960920
3439/10/028, 2010/50150-0
No
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
October 2013

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