Project 4: ACHIEVE PATHFINDER
Recruiting · NCT06070428 · Interventional (participants receive a specific treatment) · Lead sponsor: Henry Ford Health System
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- Currently in the emergency room or hospitalized with plan to be discharged to home, or
- Diagnosis of heart failure
- BNP\>200 ng/L or NTproBNP\>1000 ng/L during hospitalization or within 1 month prior to screening
- Expected ability to fully participate in study (can tolerate study processes, no long travel)
Exclusion criteria
- Hemodialysis dependent
- If dialysis is being considered by participant's care team and their eGFR value is \<30 mL/min/1.73 sq m
- Life expectancy of less than one year
- Inability to provide written informed consent
- Age less than 18 years old
- Patients with a left ventricular assist device (LVAD)
- Heart transplant recipients
- Individuals who regularly use a HEPA air cleaner in their home at screening
- Current smokers of nicotine or marijuana
- Severe aortic or mitral valve disease
- 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)
- If the PI decides for any reason that participation in the trial is not in the best interest of the patient
Where it is running
1 location listed across 1 US state.
- Henry Ford Health - Detroit, Michigan, United States