Project 4: ACHIEVE PATHFINDER

NCT06070428 | Recruiting

• 1 other identifier: 16658
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 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. 1.Change in NTproBNP from baseline to 90 days
2. 2.Home PM2.5 levels from baseline to 90 days
3. 3.Clinical events such as death and hospitalization will be monitored

Conditions

Heart Failure

Keywords

Health Disparities; Portable Air Cleaner; Exposure; Air Pollution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Baseline to 90 days

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

  Baseline to 90 days

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

  Baseline to 90 days

Other Outcomes (3)

• Impact of PAC on hsCRP

  30 and 90 days post-enrollment

• Impact of PAC use on health status

  Baseline, 30 and 90 days post enrollment

• Impact of PAC on hsTroponin

  30 and 90 days post-enrollment

Study Arms (2)

PAC Intervention Arm

ACTIVE COMPARATOR

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

Control non-interventional Arm

SHAM COMPARATOR

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

Interventions

PAC provision at hospital discharge OTHER

Patients randomized to receive the intervention will receive two PACs fitted with True HEPA filters.

Also known as: Portable Air Cleaner HEPA Filter

PAC Intervention Arm

Control non-intervention; PAC without filter OTHER

Patients randomized to the control non-interventional arm will receive two PACs with no filters inserted.

Also known as: PAC with Sham

Control non-interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Age less than 18 years old
• Patients with a left ventricular assist device (LVAD)
• Heart transplant recipients
• Individuals who regularly use a HEPA air cleaner in their home at screening
• Current smokers of nicotine or marijuana
• Severe aortic or mitral valve disease
• 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)
• If the PI decides for any reason that participation in the trial is not in the best interest of the patient

Sponsors & Collaborators

• Henry Ford Health System: lead
• Wayne State University: collaborator

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Chromosomes, Artificial, P1 Bacteriophage; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chromosomes, Artificial; Chromosomes; Genetic Structures; Genetic Phenomena; Genetic Vectors

Study Officials

• David Lanfear, MD

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Whitney Cabral, MS

CONTACT

313-874-1887; WCABRAL1@hfhs.org

Samantha Hochstadt, MS

CONTACT

313-874-7112; shochst1@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators will use mixed block sizes (2, 4, 6) for randomizing participants. Control versus PAC interventional units will be prepared by study staff who will not directly enroll patients. The crosswalk for patient study ID and randomization status will be kept in a secure separate location so that PI and staff in charge of data analysis will not be aware of randomization status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician

Model 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.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 6, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)