Using portable air cleaners to improve heart failure outcomes
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)
This study is testing if giving portable air cleaners to heart failure patients when they leave the hospital can help them feel better by reducing their exposure to air pollution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT06070428 on ClinicalTrials.gov |
What this trial studies
The ACHIEVE-P4: PATHFINDER project is a randomized, blinded clinical trial that provides portable air cleaners to heart failure patients at the time of hospital discharge. This study aims to assess whether reducing exposure to air pollution can improve clinical outcomes for these patients, particularly among those from disadvantaged backgrounds. Participants will be randomly assigned to receive either an active air cleaner or a sham device, and will also be provided with a PM2.5 sensor to monitor air quality in their homes. The trial is part of a broader initiative to address health disparities related to cardiometabolic conditions in urban populations.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized heart failure patients who are being discharged and have elevated levels of BNP or NTproBNP.
Not a fit: Patients who are on hemodialysis, have a life expectancy of less than one year, or have a left ventricular assist device will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes and reduce hospital readmissions for heart failure patients exposed to high levels of air pollution.
How similar studies have performed: While the use of portable air cleaners is an emerging approach, previous studies have indicated that air pollution negatively impacts heart failure outcomes, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: David Lanfear, MD — Henry Ford Health
- Study coordinator: Whitney Cabral, MS
- Email: WCABRAL1@hfhs.org
- Phone: 313-874-1887
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.