Clinical trial NCT01960920: Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure
Official title: Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure to Pollution
Heart Failure
Keywords: Air Pollution
Heart Failure
Endothelium
Autonomic Dysfunction
Cardiopulmonary Exercise Test
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: LABORATÓRIO DE INSUFICIÊNCIA CARDÍACA E TRANSPLANTE INCOR/HCFMUSP
name: LABORATÓRIO DE POLUIÇÃO ATMOSFÉRICA EXPERIMENTAL (LPAE/ FMUSP).
First posted: 2013-10-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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

Eligibility 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.

Primary outcomes:
measure: Endothelial Function
timeFrame: six months
Secondary outcomes:
measure: Heart rate variability
timeFrame: six months
measure: Inflammatory Markers
timeFrame: 12 months
measure: Six-minute walking test
timeFrame: Six months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Failure Lab. Incor HCFMUSP
Study officials:
affiliation: Heart Failure Lab. Coordinator
name: Edimar A Bocchi, pHD
role: STUDY_CHAIR
References:
citation: 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.