| NCT ID | NCT06070428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henry Ford Health System |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-12-18 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2023-12-18 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
David Lanfear, MD
PRINCIPAL INVESTIGATOR
Henry Ford Health
Frequently Asked Questions
Who can join the NCT06070428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070428 currently recruiting?
Yes, NCT06070428 is actively recruiting participants. Contact the research team at WCABRAL1@hfhs.org for enrollment information.
Where is the NCT06070428 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT06070428 clinical trial?
NCT06070428 is sponsored by Henry Ford Health System. The principal investigator is David Lanfear, MD at Henry Ford Health. The trial plans to enroll 400 participants.
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