Henry Ford Health
Detroit, Michigan, 48202, United States
Location status: Recruiting
NCT Number: NCT06070428
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Detroit, Michigan, 48202, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.
Other names: Portable Air Cleaner HEPA Filter
Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.
Other names: PAC with Sham
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).
Time frame: Baseline to 90 days
Each participant will be provided an indoor PM2.5 sensor to measure in-home PM2.5 levels
Time frame: Baseline to 90 days
Clinical events such as death will be monitored primarily by EMR data.
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.
Time frame: 30 and 90 days post-enrollment
hsCRP and hsTroponin will be measured at 30 and 90 days post-enrollment
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.
Time frame: 30 and 90 days post-enrollment
hsTroponin will be measured at 30 and 90 days post-enrollment
Contact information is provided by the study sponsor or research team.
Samantha Hochstadt, MS
CONTACT
Whitney Cabral, MS
CONTACT
Henry Ford Health System
Other
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
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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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