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| Name | Class |
|---|---|
| Wayne State University | OTHER |
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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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAC provision at hospital discharge | Other | Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline at hospital discharge to 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 90 days |
| The effect of PAC use on clinical events (death) in the active PAC group versus sham group |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of PAC on hsCRP | hsCRP and hsTroponin will be measured at 30 and 90 days post-enrollment | 30 and 90 days post-enrollment |
| Impact of PAC use on health status | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Whitney Cabral, MS | Contact | 313-874-1887 | WCABRAL1@hfhs.org | |
| Samantha Hochstadt, MS | Contact | 313-874-7112 | shochst1@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| David Lanfear, MD | Henry Ford Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health | Recruiting | Detroit | Michigan | 48202 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 25, 2025 | Jun 26, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D027042 | Chromosomes, Artificial, P1 Bacteriophage |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D022201 | Chromosomes, Artificial |
| D002875 | Chromosomes |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
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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.
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The investigators will use mixed block sizes (2, 4, 6) for randomizing participants. Control versus PAC interventional units will be prepared by study staff who will not directly enroll patients. The crosswalk for patient study ID and randomization status will be kept in a secure separate location so that PI and staff in charge of data analysis will not be aware of randomization status.
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| Control non-intervention; PAC without filter | Other | Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted. |
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Clinical events such as death will be monitored primarily by EMR data. |
| 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. | Baseline to 90 days |
| Baseline, 30 and 90 days post enrollment |
| Impact of PAC on hsTroponin | hsTroponin will be measured at 30 and 90 days post-enrollment | 30 and 90 days post-enrollment |
| D005822 |
| Genetic Vectors |