PAC Provision for Heart Failure

(PATHFINDER Trial)

Recruiting in Detroit (>99 mi)

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

Trial Summary

What is the purpose of this trial?

ACHIEVE-P4: PATHFINDER is a randomized, blinded clinical trial of portable air cleaners (PAC) provided at the time of hospital discharge to Heart Failure (HF) patients. It will be carried out at Henry Ford Hospitals. This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality. The ACHIEVE GREATER Center involves several separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. The present study is Project 4 (Aim 1) a randomized clinical trial titled: Portable Air cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER), of the ACHIEVE GREATER Center.

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 data supports the effectiveness of this treatment for heart failure?

Research shows that using portable air cleaners can reduce indoor air pollution, which is linked to better respiratory health in people with conditions like COPD (a lung disease). This suggests that similar benefits might be possible for heart health, as air pollution is a known risk factor for heart disease. ^{1 2 3 4 5}

How is the Portable Air Cleaner treatment for heart failure different from other treatments?

The Portable Air Cleaner treatment for heart failure is unique because it involves using devices to improve air quality, which is different from traditional heart failure treatments that typically involve medications or surgical procedures. This approach focuses on environmental factors rather than directly targeting heart function. ^{6 7 8 9 10}

Research Team

David Lanfear, MD

Principal Investigator

Henry Ford Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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). [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of using personal-level indoor air cleaners and respirators on biomarkers of cardiorespiratory health: a systematic review. [2022]

3. United States 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. [2023]

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

Patterns and Predictors of Air Cleaner Adherence Among Adults with COPD. [2022]

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

Managing chronic airflow obstruction: Part II. [2005]

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

Mobility and Ambulation for Patients with Pulmonary Artery Catheters: A Retrospective Descriptive Study. [2020]

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

Right heart catheterization in acute respiratory failure. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Pulmonary artery catheters for adult patients in intensive care. [2022]

9. United States 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. [2019]

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

Pulmonary artery catheters in cardiovascular disease. [2019]