Project 4: ACHIEVE PATHFINDER
NCT06070428 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-05-08
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
Conditions
Interventions
- OTHER
-
PAC provision at hospital discharge
Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.
- OTHER
-
Control non-intervention; PAC without filter
Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.
Sponsors & Collaborators
- collaborator OTHER
-
Henry Ford Health System
lead OTHER
Principal Investigators
-
David Lanfear, MD · Henry Ford Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-18
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
Countries
- United States
Study Locations
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