Air Filtration for Heart Disease

(SAPIA Trial)

Overseen By Junfeng Zhang, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Dementia, Alzheimer's, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if using special air filters in homes can help people with heart disease by cleaning the air they breathe. The goal is to see if reducing indoor air pollution can slow down the worsening of their heart condition.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How does HEPA filtration as a treatment for heart disease differ from other treatments?

HEPA filtration is unique because it focuses on reducing indoor air pollution, specifically fine particulate matter, which can have cardiovascular health benefits. Unlike traditional heart disease treatments that often involve medication or lifestyle changes, this approach uses air filters to improve air quality and potentially reduce heart disease risk. ^{1 2 3 4 5}

Who Is on the Research Team?

Zhanghua Chen, PhD

Principal Investigator

University of Southern California

Junfeng Zhang, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Adults aged 65-84 living in Los Angeles County with a history of ischemic heart disease, clinically stable for the past 6 months, and weighing at least 110 pounds can join. Smokers or those with certain health conditions like active cancer treatments or degenerative diseases are excluded.

Inclusion Criteria

I am between 65 and 84 years old.

Live in the Los Angeles County

I weigh at least 110 pounds.

Exclusion Criteria

Your home cannot accommodate air purifiers and air pollution monitors.

I have a degenerative nervous system condition like dementia or Alzheimer's.

Your home already has HEPA filters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HEPA Filtration Intervention

Participants receive true HEPA filtration to reduce indoor PM2.5 levels

9 months

3 visits (in-person) before, middle, and after intervention

Wash-out Period

Participants undergo a wash-out period between interventions

3 months

Sham Filtration Intervention

Participants receive sham filtration with HEPA filter removed

9 months

3 visits (in-person) before, middle, and after intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HEPA filtration
• Sham filtration

Trial Overview The trial is testing if using HEPA air filters in homes can slow down the worsening of atherothrombosis (blood clotting in hardened arteries) compared to sham (fake) filters by reducing fine particle pollution indoors.

How Is the Trial Designed?

Group I: Sham first and HEPA Experimental Treatment 2 Interventions

This group of participants will be assigned to the intervention of sham filtration with HEPA filter removed at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to the HEPA filtration for 9 months.

Group II: HEPA first and sham Experimental Treatment 2 Interventions

This group of participants will be assigned to the intervention of HEPA filtration with the capacity to reduce indoor PM2.5 levels at their residence for 9 months first. After 3-month wash-out period, participants will be assigned to sham filters (air purifier has the same appearance but HEPA filter is removed) for 9 months.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

Published Research Related to This Trial

HEPA filters demonstrate exceptional filtration efficiency, achieving over 99.97% removal of particles as small as 0.3 micrometers, which is crucial for maintaining air quality.

In tests with bacterial aerosols, three types of HEPA filters achieved 100% bacterial filtration efficiency, while other filters like NBS-95 and NBS-85 also performed well, showing over 99% efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of bacterial filtration in various commercial air filters for hospital air conditioning. Furuhashi, M.[2006]

Electret filters (EE) initially remove particles more effectively than high-efficiency filters (HE) in the 0.3-3.5 μm size range, but their efficiency decreases significantly over time, dropping to 60% after processing 25 × 10⁴ m³/m² of air.

Portable air cleaners (PAC) with a combination of pre-filters and high-efficiency filters (PR&HE) achieved the highest single-pass efficiency for PM1.0 at 88.6%, indicating that filter combinations can enhance particle removal but may also reduce airflow rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental Study on Ultrafine Particle Removal Performance of Portable Air Cleaners with Different Filters in an Office Room. Ma, H., Shen, H., Shui, T., et al.[2018]

The use of HEPA air filters significantly reduced indoor concentrations of traffic-related airborne particles, which are linked to asthma issues in children.

Children with poorly controlled asthma showed notable improvements in asthma control and quality of life after using HEPA filtration, indicating its potential as an effective intervention for managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HEPA filtration improves asthma control in children exposed to traffic-related airborne particles. James, C., Bernstein, DI., Cox, J., et al.[2021]

Air filtration is an effective environmental control measure for patients with allergic respiratory diseases, with options including whole house systems, portable air cleaners, and specialized sleep zone filters.

High-efficiency particulate air (HEPA) filters in various forms have been shown to provide significant benefits in reducing allergens and improving respiratory health, whether used alone or in combination with other control measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of air filters and air cleaners in allergic respiratory diseases: a review of the recent literature. Sublett, JL.[2022]

The RAPIDS study demonstrated that high-efficiency particulate arrestance (HEPA) filters significantly reduce indoor PM2.5 concentrations by 60% and personal PM2.5 exposures by 53% among senior citizens in Detroit, indicating their effectiveness in improving air quality and potentially cardiovascular health.

Low-efficiency (HEPA-type) filters also provided benefits, reducing indoor PM2.5 concentrations by 52% and personal exposures by 31%, suggesting that even less efficient filters can contribute to lowering harmful air pollution levels indoors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. Maestas, MM., Brook, RD., Ziemba, RA., et al.[2021]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Efficiency of bacterial filtration in various commercial air filters for hospital air conditioning. [2006]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Experimental Study on Ultrafine Particle Removal Performance of Portable Air Cleaners with Different Filters in an Office Room. [2018]

3. England pubmed.ncbi.nlm.nih.gov

HEPA filtration improves asthma control in children exposed to traffic-related airborne particles. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of air filters and air cleaners in allergic respiratory diseases: a review of the recent literature. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Reduction of personal PM2.5 exposure via indoor air filtration systems in Detroit: an intervention study. [2021]