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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01960920
Other study ID # 3439/10/028
Secondary ID 2010/50150-0
Status Completed
Phase N/A
First received October 9, 2013
Last updated August 24, 2015
Start date February 2013
Est. completion date January 2015

Study information

Verified date August 2015
Source InCor Heart Institute
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2015
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Filtered diesel exhaust
Mask-filtered exposure to diesel exhaust
Unfiltered diesel exhaust
Diesel Exhaust Inhalation
Clean air
No pollution and no filter mask

Locations

Country Name City State
Brazil Heart Failure Lab. Incor HCFMUSP São Paulo

Sponsors (4)

Lead Sponsor Collaborator
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).

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
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