Recruiting

Portable Air Cleaners

Sponsor:

Henry Ford Health System

Code:

NCT06070428

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PAC provision at hospital discharge

Control non-intervention; PAC without filter

Study Details

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

Conditions

Heart Failure

Study ID

NCT06070428

Start date

Dec 18, 2023

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PAC Intervention Arm

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.

sham comparator: Control non-interventional Arm

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.

Interventions

PAC provision at hospital discharge

Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.

Control non-intervention; PAC without filter

Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.

Primary outcome measure

  • The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level. [ Time Frame: Baseline at hospital discharge to 90 days. ]

Central Contacts and Locations

Central contacts

Whitney Cabral, MS

313-874-1887WCABRAL1@hfhs.org

Samantha Hochstadt, MS

313-874-7112shochst1@hfhs.org

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Whitney Cabral

13138741887WCABRAL1@hfhs.org

More Information

Sponsor

Henry Ford Health System

Last update posted

Jul 7, 2026

Last verified

May, 2026

Keywords

  • Health Disparities
  • Portable Air Cleaner
  • Exposure
  • Air Pollution

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-07-07.