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NCT Number: NCT06070428

Project 4: ACHIEVE 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.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Whitney Cabral

CONTACT

[email protected]

13138741887

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAC provision at hospital discharge

Other

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

Other names: Portable Air Cleaner HEPA Filter

Control non-intervention; PAC without filter

Other

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

Other names: PAC with Sham

Primary outcomes

  1. 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).

Secondary outcomes

  1. The effect of PAC use on home PM2.5 levels in active PAC group versus sham group

    Time frame: Baseline to 90 days

    Each participant will be provided an indoor PM2.5 sensor to measure in-home PM2.5 levels

  2. The effect of PAC use on clinical events (death) in the active PAC group versus sham group

    Time frame: Baseline to 90 days

    Clinical events such as death will be monitored primarily by EMR data.

  3. The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group

    Time frame: Baseline to 90 days

    Clinical events will be monitored primarily by EMR data, but patients will also be queried at study visits regarding hospitalization.

Other outcomes

  1. Impact of PAC on hsCRP

    Time frame: 30 and 90 days post-enrollment

    hsCRP and hsTroponin will be measured at 30 and 90 days post-enrollment

  2. Impact of PAC use on health status

    Time frame: Baseline, 30 and 90 days post enrollment

    Change in health status will be evaluated by use of the Kansas City Cardiomyopathy Questionnaire (KCCQ) a validated health status tool for detecting clinically important changes. The score will be represented on a 0-to-100 scale; lower scores represent more severe symptoms and scores of 100 represent no limitations.

  3. Impact of PAC on hsTroponin

    Time frame: 30 and 90 days post-enrollment

    hsTroponin will be measured at 30 and 90 days post-enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Hochstadt, MS

CONTACT

[email protected]

313-874-7112

Whitney Cabral, MS

CONTACT

[email protected]

313-874-1887

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Wayne State University

Registry information

Official study 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)

Acronym: PATHFINDER

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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