Exposure to PollutionNCT01960920
Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure
A study testing Filtered diesel exhaust, Unfiltered diesel exhaust and Clean air in people with Exposure to Pollution and Heart Failure, run by InCor Heart Institute at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exposure to Pollution, Heart Failure
- What is being tested?
- Filtered diesel exhaust, Unfiltered diesel exhaust and Clean air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NYHA I-III;
- Left Ventricle Ejection Fraction < 50%;
- Clinical condition stable for more than three months prior to the randomization;
Who cannot join
- Severe arterial hypertension;
- Severe Pulmonary disease;
- Patients with pace-markers;
- Patients with constrictive pericarditis;
- Severe chronic kidney disease;
- Patients with pulmonary hypertension;
Show all 10Show fewer
- Stroke within the last six months;
- Severe hepatic disease;
- Patients with musculoskeletal limitations to exercise;
- Patients with cardiac cachexia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial
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.
Read the 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
- Conditions
- Exposure to Pollution, Heart Failure
- Being tested
- Filtered diesel exhaust, Unfiltered diesel exhaust, Clean air
- Keywords
- Air Pollution, Heart Failure, Endothelium, Autonomic Dysfunction, Cardiopulmonary Exercise Test
- Medical subject headings
- Heart Failure, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filtered diesel exhaustOther
Also called Filter Mask 8812 (www.3m.com.br)
Mask-filtered exposure to diesel exhaust
Unfiltered diesel exhaustOther
Also called Diesel Generator Toyama TD-2500 C, www.toyama.com.br
Diesel Exhaust Inhalation
Clean airOther
No pollution and no filter mask
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | Dilute diesel exhaust Filtered diesel exhaust Filtered air Receives: Other: Filtered diesel exhaust; Other: Unfiltered diesel exhaust; Other: Clean air |
| Heart Failure patients | Experimental | Dilute diesel exhaust Filtered diesel exhaust Filtered air Receives: Other: Filtered diesel exhaust; Other: Unfiltered diesel exhaust; Other: Clean air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months
Secondary outcomes (3)
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.
Measured: six months
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.
Measured: 12 months
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exposure to PollutionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- 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).
- Responsible party
- Principal investigator, Jefferson Luis Vieira, InCor Heart Institute
- Investigators
- Edimar A Bocchi, pHD, Study chair, Heart Failure Lab. Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960920
- Sponsor's protocol ID
- 3439/10/028
- Other IDs
- 2010/50150-0
- Status last verified
- Aug 2015
- First submitted
- 9 Oct 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26738952
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure: a Prospective Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT01960920
- Acronym / sponsor ID
- 3439/10/028
- Conditions
- Exposure to Pollution, Heart Failure
- Keywords
- Air Pollution, Heart Failure, Endothelium, Autonomic Dysfunction, Cardiopulmonary Exercise Test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Collaborators
- 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).
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Other: Filtered diesel exhaust, Other: Unfiltered diesel exhaust, Other: Clean airDilute diesel exhaust Filtered diesel exhaust Filtered air |
| Heart Failure patients | Experimental | Other: Filtered diesel exhaust, Other: Unfiltered diesel exhaust, Other: Clean airDilute diesel exhaust Filtered diesel exhaust Filtered air |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- NYHA I-III;
- Left Ventricle Ejection Fraction < 50%;
- Clinical condition stable for more than three months prior to the randomization;
Key exclusion criteria (10 listed)
- Severe arterial hypertension;
- Severe Pulmonary disease;
- Patients with pace-markers;
- Patients with constrictive pericarditis;
- Severe chronic kidney disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Filtered diesel exhaustAlso: Filter Mask 8812 (www.3m.com.br)Mask-filtered exposure to diesel exhaust | Other | Healthy Volunteers, Heart Failure patients |
| Unfiltered diesel exhaustAlso: Diesel Generator Toyama TD-2500 C, www.toyama.com.brDiesel Exhaust Inhalation | Other | Healthy Volunteers, Heart Failure patients |
| Clean airNo pollution and no filter mask | Other | Healthy Volunteers, Heart Failure patients |
Primary outcome
Endothelial Function
Time frame: 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.
3 secondary outcomes
Heart rate variability
Time frame: six months
Inflammatory Markers
Time frame: 12 months
Six-minute walking test
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 26738952Vieira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edimar A Bocchi, pHD study chair
Heart Failure Lab. Coordinator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Filtered diesel exhaust, Unfiltered diesel exhaust and Clean air in people with Exposure to Pollution and Heart Failure, run by InCor Heart Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01960920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.