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Project 4: ACHIEVE PATHFINDER

ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the GREAT LakEs Region Project 4: Portable Air Cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether portable air cleaners with HEPA filters help people with heart failure after they leave Henry Ford Hospitals. Heart failure means the heart does not pump blood as well as it should. Each person gets two air cleaners, with or without HEPA filters, and a sensor to measure tiny particles in their home’s air.

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 In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A). The ACHIEVE GREATER Center involves several separate but related projects that aim to prolong lifespan among Detroit, MI and Cleveland, OH, for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Projects 2 \& 4) and coronary heart disease (CHD, Project 3). 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. Project 4 is a randomized, double-blind, parallel limb trial of 400 patients with hospitalized HF who will be provided active PAC vs sham at discharge from HFH. Participants will receive two PACs at discharge and an indoor PM2.5 sensor. PACs will be randomized to either active PAC with HEPA filters or sham PAC without HEPA filters. Researchers will compare the following outcomes of the two groups (more outcomes below in Outcome Measures section): 1. Change in NTproBNP from baseline to 90 days 2. Home PM2.5 levels from baseline to 90 days 3. Clinical events such as death and hospitalization will be monitored

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be in the emergency room or hospital with plans to go home, or have a heart failure diagnosis.
  • Have a BNP blood test result above 200 ng/L or an NTproBNP result above 1,000 ng/L during the hospital stay or in the month before screening. These tests measure signs of heart strain.
  • Be able to take part in all study steps, without long trips away.

Who can't join

  • Need hemodialysis, a treatment that filters the blood; or have an eGFR kidney test below 30 while the care team is considering dialysis.
  • Be expected to live less than one year, or be unable to give written consent to join.
  • Be younger than 18.
  • Have a left ventricular assist device (LVAD), a pump that helps the heart, or have had a heart transplant.
  • Regularly use a HEPA air cleaner at home at screening, or currently smoke nicotine or marijuana.
  • Have severe disease of the aortic or mitral valve, which help control blood flow through the heart.
  • Have a scheduled heart procedure meant to treat, not just diagnose, a problem within 30 days before or 90 days after screening.
  • Have the study leader decide that joining is not in your best interest.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Currently in the emergency room or hospitalized with plan to be discharged to home, or 2. Diagnosis of heart failure 3. BNP\>200 ng/L or NTproBNP\>1000 ng/L during hospitalization or within 1 month prior to screening 4. Expected ability to fully participate in study (can tolerate study processes, no long travel) Exclusion Criteria: 1. Hemodialysis dependent 2. If dialysis is being considered by participant's care team and their eGFR value is \<30 mL/min/1.73 sq m 3. Life expectancy of less than one year 4. Inability to provide written informed consent 5. Age less than 18 years old 6. Patients with a left ventricular assist device (LVAD) 7. Heart transplant recipients 8. Individuals who regularly use a HEPA air cleaner in their home at screening 9. Current smokers of nicotine or marijuana 10. Severe aortic or mitral valve disease 11. Has a scheduled, non-diagnostic cardiac procedure within 30 days prior, or in the next 90 days from screening (e.g. PCI, resynchronization, any cardiac surgery) 12. If the PI decides for any reason that participation in the trial is not in the best interest of the patient

Study sites (1)

MI