Clinical trial NCT06070428: Project 4: ACHIEVE PATHFINDER
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Health Disparities
Portable Air Cleaner
Exposure
Air Pollution
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2023-10-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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 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.

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).

Eligibility criteria: Inclusion Criteria:

1. Currently in the emergency room or hospitalized with plan to be discharged to home, or
2. Diagnosis of heart failure
3. BNP\>200 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. If dialysis is being considered by participant's care team and their eGFR value is \<30 mL/min/1.73 sq m
3. Life expectancy of less than one year
4. Inability to provide written informed consent
5. Age less than 18 years old
6. Patients with a left ventricular assist device (LVAD)
7. Heart transplant recipients
8. Individuals who regularly use a HEPA air cleaner in their home at screening
9. Current smokers of nicotine or marijuana
10. Severe aortic or mitral valve disease
11. Has a scheduled, non-diagnostic cardiac procedure within 30 days prior, or in the next 90 days from screening (e.g. PCI, resynchronization, any cardiac surgery)
12. If the PI decides for any reason that participation in the trial is not in the best interest of the patient

Primary outcomes:
measure: The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level.
timeFrame: Baseline at hospital discharge to 90 days.
Secondary outcomes:
measure: The effect of PAC use on home PM2.5 levels in active PAC group versus sham group
timeFrame: Baseline to 90 days
measure: The effect of PAC use on clinical events (death) in the active PAC group versus sham group
timeFrame: Baseline to 90 days
measure: The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group
timeFrame: Baseline to 90 days
Other outcomes:
measure: Impact of PAC on hsCRP
timeFrame: 30 and 90 days post-enrollment
measure: Impact of PAC use on health status
timeFrame: Baseline, 30 and 90 days post enrollment
measure: Impact of PAC on hsTroponin
timeFrame: 30 and 90 days post-enrollment
Locations:
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
affiliation: Henry Ford Health
name: David Lanfear, MD
role: PRINCIPAL_INVESTIGATOR
References: