RecruitingNot ApplicableNCT06070428

Project 4: ACHIEVE PATHFINDER

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)


Sponsor

Henry Ford Health System

Enrollment

400 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called ACHIEVE PATHFINDER, helps people recently hospitalized for heart failure get better support after they go home. It tests whether a coordinated care program can reduce hospital readmissions and improve how patients manage their heart condition day to day. **You may be eligible if...** - You are currently in the emergency room or hospital and are about to be discharged home, OR - You have been diagnosed with heart failure - Your heart failure lab values (BNP or NTproBNP) show elevated levels during your hospital stay or within the past month - You are able to fully participate in the study **You may NOT be eligible if...** - You are on dialysis for kidney failure - Your kidney function is very poor (eGFR below 30) and your care team is considering dialysis - You have a life expectancy of less than 6 months - Long travel requirements would prevent your participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPAC provision at hospital discharge

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

OTHERControl non-intervention; PAC without filter

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


Locations(1)

Henry Ford Health

Detroit, Michigan, United States

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NCT06070428


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