Project 4: ACHIEVE PATHFINDER

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06070428
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PAC provision at hospital discharge — OTHER
    Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.
  • Control non-intervention; PAC without filter — OTHER
    Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.

Study Details

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

Key Dates

Start date
Dec 18, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: PAC Intervention Arm
    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.
  • Sham Comparator: Control non-interventional Arm
    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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford HealthDetroitMichigan48202
Whitney Cabral
[email protected]
13138741887

Find similar trials in Detroit, MI

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Henry Ford Health· Detroit, MI

Related Studies