Project 4: ACHIEVE PATHFINDER (PATHFINDER)

ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region Project 4: Portable Air Cleaners to Treat Heart Failure and Negate Disparities of Environment and Race (PATHFINDER)

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 Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality. The ACHIEVE GREATER Center involves several separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. 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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: PAC provision at hospital discharge; Other: Control non-intervention; PAC without filter

Detailed Description

Heart failure (HF) is one of the most common, costly, and deadly diseases affecting humans. Health disparities persist whereby HF-related morbidity and mortality are greater in Black populations for a number of reasons yet to be fully understood. While the distribution of multiple negative social determinants of health (SDoH) certainly plays a key role, growing evidence further implicates an outsized adverse impact from environmental factors among urban dwelling populations. In this regard, a number of studies show that air pollutants adversely impact HF and its prognosis. As such, the investigators believe that air pollution is a form of environmental racism and a significant contributor to poor 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, the investigators propose to test the effectiveness of portable air cleaners (PACs), an emerging therapeutic intervention, that the investigators hypothesize will reduce personal-level exposure to PM2.5 resulting in improved clinical outcomes for HF patients.

Patients will be enrolled at hospital discharge and randomly assigned to active PAC vs. sham PAC (a PAC without a HEPA filter inside it). Two PACs will be given to each patient to place in the home after discharge (one in bedroom and one in living space). The study will also provide one PM2.5 sensor for each participant home.

Follow-up in-person visits will be scheduled at 30 and 90- days after randomization and will be completed to draw blood for biomarkers, measure blood pressure, health status (Kansas City Cardiomyopathy Questionnaire, KCCQ), functional status (6 minute walk distance), and assess for occurrence of clinical events (i.e. re-hospitalization or death). The biomarkers include measures of heart failure disease activity (NTproBNP), inflammation (CRP) and cardiac injury (high sensitivity troponin).

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Whitney Cabral, MS; Phone Number: 313-874-1887; Email: wcabral1@hfhs.org
• Study Contact Backup: Name: Samantha Hochstadt, MS; Phone Number: 313-874-7112; Email: shochst1@hfhs.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Whitney Cabral; Phone Number: 313-874-1887; Email: WCABRAL1@hfhs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Currently hospitalized with plan to be discharged to home
2. Primary discharge diagnosis heart failure
3. BNP>300 ng/L or NTproBNP>1000 ng/L during hospitalization or within 1 month prior to screening.
4. Expected ability to fully participate in study (can tolerate study processes, no long travel)

Exclusion Criteria:

1. Hemodialysis dependent
2. Life expectancy of less than one year
3. Inability to provide written informed consent
4. Age less than 18 years old

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: PAC provision at hospital discharge; Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.; Other Names: Portable Air Cleaner HEPA Filter
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.	Other: Control non-intervention; PAC without filter; Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.; Other Names: PAC with Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Collaborators: Wayne State University
• Investigators: Principal Investigator: David Lanfear, MD, Henry Ford Health

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Air Pollution; Health Disparities; Exposure; Portable Air Cleaner
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 16658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No