PAC Provision for Heart Failure

(PATHFINDER Trial)

Overseen By Samantha Hochstadt, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Dialysis, Life expectancy <1 year, LVAD, Heart transplant, Current smoker, 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: 3

Duration: 12 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether portable air cleaners can aid people with heart failure by reducing harmful particles in the air when they return home from the hospital. Researchers aim to determine if these air cleaners can enhance heart health and decrease hospital visits. Participants will receive portable air cleaners either with special filters or without, and their air quality and health will be monitored. Individuals who have been hospitalized for heart failure, are returning home, and do not already use a HEPA air cleaner are suitable candidates for this trial. As an unphased trial, this study provides participants the chance to contribute to significant research that could improve heart health for many.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that portable air cleaners are safe for heart failure patients?

Research has shown that portable air cleaners (PACs) effectively reduce indoor air pollution. Some studies have found that these devices can lower indoor pollution levels by 50-60%, a significant reduction.

Additionally, other research suggests that PACs might help lower blood pressure. For instance, one study found that people with high blood pressure experienced a noticeable drop after using air purifiers for a month. Another study demonstrated positive effects on heart health with just 9 to 10 hours of use.

These findings suggest that PACs are generally safe and do not pose major risks for users. They seem to offer health benefits, especially for those with existing heart conditions. While the FDA has not approved these devices as medical treatments, current research indicates they are safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using portable air cleaners (PACs) with HEPA filters for heart failure patients because they offer a unique, non-invasive approach to potentially improving heart health. Unlike traditional treatments that rely on medications or devices to manage heart failure, these air cleaners aim to enhance indoor air quality, which could indirectly support cardiovascular health. By removing fine particulates and allergens from the air, PACs might reduce inflammation and stress on the heart, offering a novel way to complement existing treatments. This approach is particularly intriguing as it leverages a simple environmental modification to address a complex medical condition.

What evidence suggests that portable air cleaners are effective for heart failure?

This trial will compare the effects of Portable Air Cleaners (PACs) with and without HEPA filters on heart health. Studies have shown that PACs with HEPA filters can significantly improve heart health. Research indicates that these devices can reduce indoor air pollution by 50–60%, which is crucial because air pollution can affect heart conditions. In a previous study, participants with high blood pressure experienced a drop of about 2.8 mmHg in their systolic blood pressure after using HEPA filters for a month. Another review found that PACs can help lower both systolic and diastolic blood pressure. These findings suggest that using HEPA filters in PACs may enhance heart health by reducing harmful air particles and lowering blood pressure. ^{1 3 4 5 6}

Who Is on the Research Team?

David Lanfear, MD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

This trial is for heart failure patients currently hospitalized and soon to be discharged home, with specific blood test results indicating heart failure severity. They must be able to participate fully in the study without long travel plans.

Inclusion Criteria

I can participate in all study activities without long travel.

I am in the hospital now but will be going home soon.

My main diagnosis when discharged was heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive portable air cleaners (PAC) at the time of hospital discharge, with follow-up visits to monitor health outcomes.

12 weeks

2 visits (in-person) at 30 and 90 days post-randomization

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood pressure, biomarker levels, and health status assessments.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Control non-intervention; PAC without filter
• Portable Air Cleaners

Trial Overview The ACHIEVE PATHFINDER trial tests if portable air cleaners (PAC) given at hospital discharge can help manage heart failure. Patients are randomly assigned to receive a PAC or no intervention; some PACs have filters.

How Is the Trial Designed?

Group I: PAC Intervention Arm Active Control 1 Intervention

Participants randomized to the interventional arm will be given 2 PAC units with HEPA filters inside to be used in the home: one in the room patient sleeps in, the other in the living area of the home. Participants will also be given an air quality monitor. Study staff will educate the patient on use of the filters and monitor. Patients will be seen in clinic for 30-day and 90-day follow-up visits. Blood pressure, blood draw for biomarker levels, 6-minute walk distance, and questionnaires will be completed. Patients will be allowed to keep the PAC at the end of the trial and will be informed at that time how to purchase additional filters.

Group II: Control non-interventional Arm Placebo Group 1 Intervention

Participants randomized to the non-interventional arm will be given 2 PAC units without HEPA filters inside to be used in the home: one in the room patient sleeps in, the other in the living area of the home. Participants will also be given an air quality monitor. Study staff will educate the patient on use of the filters and monitor. Patients will be seen in clinic for 30-day and 90-day follow-up visits. Blood pressure, blood draw for biomarker levels, 6-minute walk distance, and questionnaires will be completed. Patients will be allowed to keep the PAC at the end of the trial and will be informed at that time how to purchase additional filters.

Portable Air Cleaners is already approved in United States for the following indications:

Approved in United States as Portable Air Cleaners for:

• Improvement of heart health in individuals with chronic obstructive pulmonary disease (COPD)
• Reduction of cardiovascular risks in heart failure patients

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Published Research Related to This Trial

The use of active portable high-efficiency particulate air cleaners showed a significant reduction in respiratory symptoms and moderate exacerbations in former smokers with COPD over a 6-month period, indicating potential health benefits from reducing indoor particulate matter.

Participants who adhered to using the air cleaners and spent more time indoors experienced greater improvements in their respiratory health, suggesting that these devices could be particularly effective for individuals with COPD in indoor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Air Cleaners to Improve Indoor Air Quality and Chronic Obstructive Pulmonary Disease Health: Results of the CLEAN AIR Study. Hansel, NN., Putcha, N., Woo, H., et al.[2023]

In a 6-month study involving 116 former smokers with COPD, 76.1% of participants adhered to using portable air cleaners at least 80% of the time, which could potentially improve their respiratory health by reducing indoor pollutants.

Factors such as higher household income and using electric heating were linked to better adherence, while lower quality of life and recent exacerbations were associated with lower adherence, indicating that socioeconomic and health status play crucial roles in the effectiveness of air cleaner interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Air Cleaner Adherence Among Adults with COPD. Lorizio, W., Woo, H., McCormack, MC., et al.[2022]

The use of pulmonary artery catheters (PAC) in patients with respiratory failure can lead to changes in diagnosis and therapy, indicating its potential utility in clinical decision-making.

However, there is insufficient evidence to conclusively determine the overall benefits or risks of PAC use in these patients, highlighting the need for further research to clarify its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Right heart catheterization in acute respiratory failure. Fulkerson, WJ., Bernard, GR.[2019]

A systematic review of 13 studies involving 5686 patients found that the use of pulmonary artery catheters (PAC) did not significantly affect mortality rates or length of stay in the ICU or hospital for critically ill patients.

Despite being a widely used diagnostic tool, PAC did not demonstrate any cost benefits, and further efficacy studies are needed to explore optimal management protocols that could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheters for adult patients in intensive care. Rajaram, SS., Desai, NK., Kalra, A., et al.[2022]

In a study of 5,841 hospitalized patients with acute myocardial infarction (AMI), the use of pulmonary artery catheterization (PAC) was associated with higher in-hospital mortality in patients with congestive heart failure (CHF), but not in those with cardiogenic shock or persistent hypotension.

The increased mortality observed in patients receiving PAC is likely due to the higher severity of CHF in these patients rather than a direct effect of PAC itself, suggesting that PAC does not inherently increase mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of pulmonary artery catheters in patients with acute myocardial infarction. Analysis of experience in 5,841 patients in the SPRINT Registry. SPRINT Study Group. Zion, MM., Balkin, J., Rosenmann, D., et al.[2019]

In a pilot study involving 20 elderly cardiac patients, the use of active portable air cleaners (PACs) significantly reduced personal PM2.5 exposure by 43.8% compared to sham devices, indicating their effectiveness in improving air quality for at-risk individuals.

The findings suggest that using inexpensive in-home PACs could lead to substantial long-term health benefits for cardiac patients by potentially reducing the risk of cardiovascular events, even in areas with generally good air quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT). Bard, RL., Rubenfire, M., Fink, S., et al.[2021]

In a study of 366 patients with indwelling Pulmonary Artery Catheters (PACs) in the Cardiology Intensive Care Unit, no complications were reported during various mobility activities such as bed mobility, transfers, and ambulation over a 29-month period.

The findings suggest that engaging in mobility activities does not increase the risk of PAC-related complications, highlighting the importance of involving rehabilitation specialists in the care of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobility and Ambulation for Patients with Pulmonary Artery Catheters: A Retrospective Descriptive Study. Fields, C., Trotsky, A., Fernandez, N., et al.[2020]

A well-controlled international study found that using intermittent positive pressure breathing for delivering aerosol bronchodilators does not improve life expectancy, hospitalization rates, lung function, or quality of life compared to using a standard air compressor.

For patients on a home oxygen program, standard treatment should be prioritized, and ambulatory oxygen should only be considered if hypoxemia continues after one month of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing chronic airflow obstruction: Part II. Ostrow, DN.[2005]

Pulmonary artery catheterization (PAC) is commonly used in patients with cardiovascular disease to enhance understanding of their hemodynamics and guide therapy, potentially improving patient management.

While there is a lack of prospective randomized trials demonstrating clear benefits in mortality or hard outcomes, expert opinion suggests that PAC can lead to quicker diagnoses and better therapeutic outcomes, particularly in patients with acute myocardial infarction, congestive heart failure, pulmonary hypertension, and shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheters in cardiovascular disease. Hollenberg, SM., Hoyt, J.[2019]

The systematic review of 29 studies suggests that using portable air cleaners indoors can lead to beneficial changes in cardiovascular health, including a significant 2.01% decrease in systolic blood pressure.

While respirators showed some positive effects on heart rate variability, the overall evidence for both interventions is of low certainty due to issues like small sample sizes and high risk of bias in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of using personal-level indoor air cleaners and respirators on biomarkers of cardiorespiratory health: a systematic review. Liu, S., Wu, R., Zhu, Y., et al.[2022]

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2025.06.037

Effect of HEPA Filtration Air Purifiers on Blood Pressure HEPA filtration significantly reduced PM in comparison to both indoor sham and outdoor levels. Participants' SBP at the start of the ...

2. acc.org acc.org/About-ACC/Press-Releases/2025/08/06/15/32/Air-Purifiers-May-Reduce-Heart-Risks-for-People-Exposed-to-Traffic-Pollution

Air Purifiers May Reduce Heart Risks for People Exposed ... Researchers found that participants with elevated SBP (>120 mmHg) experienced an average 2.8 mmHg reduction in SBP after one month of HEPA ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0147651323007315

An updated systematic review and meta-analysis on ... A growing number of studies have reported a beneficial effect of portable air cleaners (PACs) on systolic and diastolic BP; SBP and DBP.

4. aaqr.org aaqr.org/articles/aaqr-23-08-oa-0202

Real-World Effectiveness of Portable Air Cleaners in ... PACs equipped with filters are generally inexpensive, practical, and known to reduce indoor PM2.5 levels by typically 50–60% in experimental interventions, ...

5. ehp.niehs.nih.gov ehp.niehs.nih.gov/doi/10.1289/isee.2023.SA-127

Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes This study aims to demonstrate the feasibility, efficacy, and effectiveness of air-filters in improving indoor PM2.5 levels and improving the functional ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12320120/

Effect of portable air filtration systems among female ... Overall, this is the first study to demonstrate positive cardiovascular and metabolic impacts from 9 to 10 h of AFS usage amid hazardous air ...