Heart FailurePATHFINDERNCT06070428
Project 4: ACHIEVE PATHFINDER
A study testing PAC provision at hospital discharge in people with Heart Failure, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- PAC provision at hospital discharge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Whitney Cabral, 13138741887, WCABRAL1@hfhs.org
About this study
Official title: 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)
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.
Read more
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):
- Change in NTproBNP from baseline to 90 days
- Home PM2.5 levels from baseline to 90 days
- Clinical events such as death and hospitalization will be monitored
Read the detailed description
Project 4 of ACHIEVE GREATER aims to improve outcomes for symptomatic (Stage C) HF. This is vitally important because HF is the most common final manifestation of cardiometabolic diseases in the U.S., accounting for nearly 400,000 deaths and 900,000 hospitalizations per year. Growing evidence implicates air pollutants adversely impact HF and its prognosis. For example, among 12,474 HF patients in North Carolina, hospital readmission rates at 90-days were increased by 13-14% for every 1 μg/m3 elevation in fine particulate matter <2.5 µm air pollution (PM2.5) levels. While average U.S. air quality has improved, urban communities continue to have higher levels of exposure. Indeed, Detroit residents face the highest PM2.5 concentrations in Michigan (97th percentile for the U.S.). We hypothesize that this may contribute to worse outcomes among HF patients in Detroit, including an unacceptably high rate of death or rehospitalization (22% based on Henry Ford Health [HFH] data for 2022) at 90-days post-discharge. To combat this problem, we propose to test an emerging therapeutic intervention, the portable air cleaner (PAC), that we hypothesize will reduce personal-level exposure to PM2.5 resulting in improved clinical outcomes for HF patients. This novel intervention is both practical and scalable, and thus has the potential to revolutionize the treatment of HF and improve related outcomes nationwide.
- Conditions
- Heart Failure
- Being tested
- PAC provision at hospital discharge, Control non-intervention; PAC without filter
- Keywords
- Health Disparities, Portable Air Cleaner, Exposure, Air Pollution
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAC provision at hospital dischargeOther
Also called Portable Air Cleaner HEPA Filter
Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.
Control non-intervention; PAC without filterOther
Also called PAC with Sham
Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.
| Study group | Role | What they receive |
|---|---|---|
| PAC Intervention Arm | Active comparator | 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. Receives: Other: PAC provision at hospital discharge |
| Control non-interventional Arm | Sham comparator | 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. Receives: Other: Control non-intervention; PAC without filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level.
Change in NTproBNP from baseline to 90 days. This will be determined by comparing the NTproBNP value at the 90-day follow up visit versus the baseline NTproBNP value measured from blood draw at enrollment/randomization visit (within 48 hours of hospital discharge).
Measured: Baseline at hospital discharge to 90 days.
Secondary outcomes (3)
The effect of PAC use on home PM2.5 levels in active PAC group versus sham group
Each participant will be provided an indoor PM2.5 sensor to measure in-home PM2.5 levels
Measured: Baseline to 90 days
The effect of PAC use on clinical events (death) in the active PAC group versus sham group
Clinical events such as death will be monitored primarily by EMR data.
Measured: Baseline to 90 days
The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group
Clinical events will be monitored primarily by EMR data, but patients will also be queried at study visits regarding hospitalization.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start18 Dec 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Principal investigator, David Lanfear, Henry Ford Health System
- Investigators
- David Lanfear, MD, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070428
- Sponsor's protocol ID
- 16658
- Acronym
- PATHFINDER
- Status last verified
- May 2026
- First submitted
- 26 Sep 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06070428
- Acronym / sponsor ID
- PATHFINDER / 16658
- Conditions
- Heart Failure
- Keywords
- Health Disparities, Portable Air Cleaner, Exposure, Air Pollution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Change in NTproBNP from baseline to 90 days
- Home PM2.5 levels from baseline to 90 days
- Clinical events such as death and hospitalization will be monitored
Detailed description
Project 4 of ACHIEVE GREATER aims to improve outcomes for symptomatic (Stage C) HF. This is vitally important because HF is the most common final manifestation of cardiometabolic diseases in the U.S., accounting for nearly 400,000 deaths and 900,000 hospitalizations per year. Growing evidence implicates air pollutants adversely impact HF and its prognosis. For example, among 12,474 HF patients in North Carolina, hospital readmission rates at 90-days were increased by 13-14% for every 1 μg/m3 elevation in fine particulate matter <2.5 µm air pollution (PM2.5) levels. While average U.S. air quality has improved, urban communities continue to have higher levels of exposure. Indeed, Detroit residents face the highest PM2.5 concentrations in Michigan (97th percentile for the U.S.). We hypothesize that this may contribute to worse outcomes among HF patients in Detroit, including an unacceptably high rate of death or rehospitalization (22% based on Henry Ford Health [HFH] data for 2022) at 90-days post-discharge. To combat this problem, we propose to test an emerging therapeutic intervention, the portable air cleaner (PAC), that we hypothesize will reduce personal-level exposure to PM2.5 resulting in improved clinical outcomes for HF patients. This novel intervention is both practical and scalable, and thus has the potential to revolutionize the treatment of HF and improve related outcomes nationwide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PAC Intervention Arm | Active comparator | Other: PAC provision at hospital dischargeParticipants 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. |
| Control non-interventional Arm | Sham comparator | Other: Control non-intervention; PAC without filterParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAC provision at hospital dischargeAlso: Portable Air Cleaner HEPA FilterPatients randomized to receive the intervention will receive two PACs fitted with True HEPA filters. | Other | PAC Intervention Arm |
| Control non-intervention; PAC without filterAlso: PAC with ShamPatients randomized to the control non-interventional arm will receive two PACs with no filters inserted. | Other | Control non-interventional Arm |
Primary outcome
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.
Change in NTproBNP from baseline to 90 days. This will be determined by comparing the NTproBNP value at the 90-day follow up visit versus the baseline NTproBNP value measured from blood draw at enrollment/randomization visit (within 48 hours of hospital discharge).
3 secondary outcomes
The effect of PAC use on home PM2.5 levels in active PAC group versus sham group
Time frame: Baseline to 90 days
The effect of PAC use on clinical events (death) in the active PAC group versus sham group
Time frame: Baseline to 90 days
The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group
Time frame: Baseline to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Lanfear, MD principal investigator
Henry Ford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAC provision at hospital discharge in people with Heart Failure, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitney Cabral, MS (313-874-1887, WCABRAL1@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.