Cleaner Air for Better Cardiac Biomarkers

Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure Via Home Air Filtration

This pilot project is a randomized, double-blind, sham-controlled trial investigating whether in-home air pollution reductions using portable air cleaners (PACs) can decrease circulating concentrations of biomarkers of inflammation. Using both a targeted approach to study the established biomarker TNFa and an exploratory approach with a commercially available proteomic panel, the researchers will measure concentrations of biomarkers before and after four weeks of home PAC use in a cohort of 74 adults with hypertension recruited from NYU outpatient clinical settings. Participants will also track home blood pressure measurements for additional exploratory analysis of potential mediation of PAC-associated decreases in blood pressure by biomarker concentration changes.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Portable air cleaner (PAC); Other: Sham Portable air cleaner (PAC)

Detailed Description

In Aim 1, the researchers will evaluate associations with PAC use with a priori specified biomarker of inflammation, tumor necrosis factor alpha (TNFα). The researchers will determine if 4 weeks of home air filtration with PACs compared to sham is associated with significant reductions in TNFα concentrations when measured before and after intervention. Blood samples will be collected from 74 study participants before and after 4 weeks of PAC use (true and sham) for biomarker concentration measurement. In Aim 2, the researchers will determine if reductions in fine particulate matter (<2.5 μm in diameter, PM2.5) as a continuous variable are associated with significant reductions TNFα concentrations over a four-week period.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant is ≥18 years old
• Participant and members of household are reported to be non-smokers (defined as no household members are currently known to smoke cigarettes or use other tobacco products including e-cigarettes)
• Participant is to understand/speak English or Spanish
• Participant can understand study procedures and give informed consent
• Participant has stable hypertension: no medication changes in prior 30 days, systolic BP <160 mm Hg and either ≥ 130 mm Hg without antihypertensive medications, or diagnosis of hypertension in medical records
• Able to measure home blood pressure twice daily
• Able to participate in video conference for home equipment setup
• Able to visit clinic for blood draws before and after the study period
• Do not intend to sleep anywhere outside of primary bedroom for more than 48 consecutive hours or a total of 7 days during the study period.
• Ability to lift, or access to assistance with lifting, 20 lb to set up PAC in bedroom.

Exclusion Criteria:

• Participants who are unable to provide a minimum of at least one blood pressure measurement per day
• Participants with average home blood pressure monitor readings of a systolic blood pressure (SBP) >160 mmHg over any 10-day period during the study. This will be considered evidence of uncontrolled hypertension and will require study termination.
• Participants with known coronary artery disease
• Participants with known systemic inflammatory conditions (such as rheumatoid arthritis, inflammatory bowel disease, cancer)
• Participants currently taking any anti-inflammatory medications or medications that target inflammatory cytokines
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable Air Cleaner (PAC) group; This study will utilize a portable air cleaner as an intervention for the potential reduction of air pollution-associated inflammation. This commercially available device has no significant risks. The researchers plan to use a commercially available PAC with a "true HEPA" filter for the true arm.	Other: Portable air cleaner (PAC); Commercially available Portable air cleaners (PAC) contain carbon filters that reduce volatile organic carbons and can reduce odors. Because of this, the researchers will remove the carbon filters from all air purifiers to preserve blinding. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.
Sham Comparator: Sham Portable Air Cleaner (PAC) group; For the sham arm, the same model will be used with HEPA filter removed, and has identical appearance and sound. The researchers will use a PAC designed to filter air in rooms up to approximately 350 ft2, with minimal noise on the lowest setting.	Other: Sham Portable air cleaner (PAC); Sham Portable air cleaner (PAC) are commercially available portable air cleaners with the carbon filters and the HEPA filters removed. This will be done by unblinded research staff and devices will be labelled with an ID number to preserve blinding of the rest of the research team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα)	Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.	Baseline, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration	Commercially available Particulate Matter (PM) monitors will record indoor PM2.5 concentrations using dual (backup) sensors, which store measurements on internal SD cards	Baseline, Week 4

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jonathan D Newman, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 22-00045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Jonathan.Newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No