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

Heart Failure Clinical Trial

Official title:

Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial

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

• Exposure to Pollution
• Heart Failure

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