RECRUITING

Project 4: ACHIEVE PATHFINDER

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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

Official Title

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

Quick Facts

Study Start:2023-12-18
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06070428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Currently in the emergency room or hospitalized with plan to be discharged to home, or
  2. 2. Diagnosis of heart failure
  3. 3. BNP\>200 ng/L or NTproBNP\>1000 ng/L during hospitalization or within 1 month prior to screening
  4. 4. Expected ability to fully participate in study (can tolerate study processes, no long travel)
  1. 1. Hemodialysis dependent
  2. 2. If dialysis is being considered by participant's care team and their eGFR value is \<30 mL/min/1.73 sq m
  3. 3. Life expectancy of less than one year
  4. 4. Inability to provide written informed consent
  5. 5. Age less than 18 years old
  6. 6. Patients with a left ventricular assist device (LVAD)
  7. 7. Heart transplant recipients
  8. 8. Individuals who regularly use a HEPA air cleaner in their home at screening
  9. 9. Current smokers of nicotine or marijuana
  10. 10. Severe aortic or mitral valve disease
  11. 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. 12. If the PI decides for any reason that participation in the trial is not in the best interest of the patient

Contacts and Locations

Study Contact

Whitney Cabral, MS
CONTACT
313-874-1887
WCABRAL1@hfhs.org
Samantha Hochstadt, MS
CONTACT
313-874-7112
shochst1@hfhs.org

Principal Investigator

David Lanfear, MD
PRINCIPAL_INVESTIGATOR
Henry Ford Health

Study Locations (Sites)

Henry Ford Health
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • David Lanfear, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-18
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-12-18
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Health Disparities
  • Portable Air Cleaner
  • Exposure
  • Air Pollution

Additional Relevant MeSH Terms

  • Heart Failure