Project 4: ACHIEVE PATHFINDER

ConditionHeart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHenry Ford Health System

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Currently in the emergency room or hospitalized with plan to be discharged to home, or

Diagnosis of heart failure

BNP>200 ng/L or NTproBNP>1000 ng/L during hospitalization or within 1 month prior to screening

Expected ability to fully participate in study (can tolerate study processes, no long travel)

Disqualifiers

Hemodialysis dependent

If dialysis is being considered by participant's care team and their eGFR value is <30 mL/min/1.73 sq m

Life expectancy of less than one year

Inability to provide written informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: PAC Intervention ArmActive comparator 1 intervention

Group B: Control non-interventional ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

Baseline at hospital discharge to 90 days.

Secondary outcomes

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

Time frame

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.

Time frame

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.

Time frame

Baseline to 90 days

Other outcomes

Impact of PAC on hsCRP

hsCRP and hsTroponin will be measured at 30 and 90 days post-enrollment

Time frame

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.

Time frame

Baseline, 30 and 90 days post enrollment

Impact of PAC on hsTroponin

hsTroponin will be measured at 30 and 90 days post-enrollment

Time frame

30 and 90 days post-enrollment