Exposure to Pollution, Heart Failure
Conditions
Keywords
Air Pollution, Heart Failure, Endothelium, Autonomic Dysfunction, Cardiopulmonary Exercise Test
Brief 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.
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 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
Interventions
OTHERFiltered diesel exhaust
Mask-filtered exposure to diesel exhaust
OTHERUnfiltered diesel exhaust
Diesel Exhaust Inhalation
OTHERClean air
No pollution and no filter mask
Sponsors
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).
InCor Heart Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Function | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate variability | 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. |
| Inflammatory Markers | 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. |
| Six-minute walking test | 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. |
Countries
Brazil
Outcome results
None listed