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Behavioural Intervention

PAC Provision for Heart Failure (PATHFINDER Trial)

N/A

Recruiting

Led By David Lanfear, MD

Research Sponsored by Henry Ford Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently hospitalized with plan to be discharged to home

Primary discharge diagnosis heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 and 90 days post-enrollment

Summary

This trial, called PATHFINDER, is part of a larger project called ACHIEVE GREATER. The goal of the project is to reduce health disparities and inequality between Black and White individuals in

Who is the study for?

This trial is for heart failure patients currently hospitalized and soon to be discharged home, with specific blood test results indicating heart failure severity. They must be able to participate fully in the study without long travel plans.

What is being tested?

The ACHIEVE PATHFINDER trial tests if portable air cleaners (PAC) given at hospital discharge can help manage heart failure. Patients are randomly assigned to receive a PAC or no intervention; some PACs have filters.

What are the potential side effects?

Since this trial involves non-invasive interventions like portable air cleaners, there are minimal expected side effects compared to drug treatments. Any potential discomfort would likely come from inconvenience or noise.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the hospital now but will be going home soon.

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My main diagnosis when discharged was heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 and 90 days post-enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 and 90 days post-enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 and 90 days post-enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The impact of PAC use for 90 days after hospital discharge for HF compared to sham on NTproBNP level.

Secondary study objectives

The effect of PAC use on clinical events (death) in the active PAC group versus sham group

The effect of PAC use on clinical events (hospitalization) in the active PAC group versus sham group

The effect of PAC use on home PM2.5 levels in active PAC group versus sham group

Other study objectives

Impact of PAC on hsCRP

Impact of PAC on hsTroponin

Impact of PAC use on health status

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PAC Intervention ArmActive Control1 Intervention

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.

Group II: Control non-interventional ArmPlacebo Group1 Intervention

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.

0 / 2Eligibility criteria met