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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
Exposure to Pollution
Heart Failure
Other: Filtered diesel exhaust
Other: Dilute diesel exhaust
Other: Filtered air

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Official Title: Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by InCor Heart Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy Volunteers
Dilute diesel exhaust Filtered diesel exhaust Filtered air
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
Experimental: Heart Failure patients
Dilute diesel exhaust Filtered diesel exhaust Filtered air
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

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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01960920

Contacts
Contact: Jefferson L Vieira, MD 55 (11) 988133085 jefvieira@yahoo.com.br
Contact: Edimar A Bocchi, pHD 55 (11) 997081692 dcledimar@incor.usp.br

Locations
Brazil
Heart Failure Lab. Incor HCFMUSP Recruiting
São Paulo, Brazil, 05403900
Contact: Jefferson L Vieira, MD    55(11)988133085    jefvieira@yahoo.com.br   
Principal Investigator: Edimar A Bocchi, pHD         
Sponsors and Collaborators
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).
Investigators
Study Chair: Edimar A Bocchi, pHD Heart Failure Lab. Coordinator
  More Information

No publications provided

Responsible Party: Jefferson Luis Vieira, MD, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT01960920     History of Changes
Other Study ID Numbers: 3439/10/028, 2010/50150-0
Study First Received: October 9, 2013
Last Updated: October 9, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by InCor Heart Institute:
Air Pollution
Heart Failure
Endothelium
Autonomic Dysfunction
Cardiopulmonary Exercise Test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014