NCT01960920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

October 9, 2013

Last Update Submit

August 24, 2015

Conditions

Exposure to PollutionHeart Failure

Keywords

Air PollutionHeart FailureEndotheliumAutonomic DysfunctionCardiopulmonary Exercise Test

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Heart rate variability

    six months

  • Inflammatory Markers

    12 months

  • Six-minute walking test

    Six months

Study Arms (2)

Healthy Volunteers

ACTIVE COMPARATOR

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Other: Filtered diesel exhaustOther: Unfiltered diesel exhaustOther: Clean air

Heart Failure patients

EXPERIMENTAL

Dilute diesel exhaust Filtered diesel exhaust Filtered air

Other: Filtered diesel exhaustOther: Unfiltered diesel exhaustOther: Clean air

Interventions

Filtered diesel exhaustOTHER

Mask-filtered exposure to diesel exhaust

Also known as: Filter Mask 8812 (www.3m.com.br)
Healthy VolunteersHeart Failure patients
Unfiltered diesel exhaustOTHER

Diesel Exhaust Inhalation

Also known as: Diesel Generator Toyama TD-2500 C, www.toyama.com.br
Healthy VolunteersHeart Failure patients
Clean airOTHER

No pollution and no filter mask

Healthy VolunteersHeart Failure patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NYHA I-III;
  • Left Ventricle Ejection Fraction \< 50%;
  • Clinical condition stable for more than three months prior to the randomization;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Failure Lab. Incor HCFMUSP

São Paulo, São Paulo, 05403900, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 26738952DERIVED

MeSH Terms

Conditions

Heart FailurePrimary Dysautonomias

Interventions

Environment, Controlled

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

EnvironmentEnvironment and Public Health

Study Officials

  • Edimar A Bocchi, pHD

    Heart Failure Lab. Coordinator

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

January 1, 2015

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

BR(1)