Cleaner Air for Better Cardiac Biomarkers

NCT05379400 | Completed Results

• 1 other identifier: 22-00045
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration

  Baseline, Week 4

Study Arms (2)

Portable Air Cleaner (PAC) group

EXPERIMENTAL

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)

Sham Portable Air Cleaner (PAC) group

SHAM COMPARATOR

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)

Interventions

Portable air cleaner (PAC) OTHER

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.

Portable Air Cleaner (PAC) group

Sham Portable air cleaner (PAC) OTHER

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.

Sham Portable Air Cleaner (PAC) group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Sharine Wittkopp
• Organization: NYU Langone Health

Sharine.Wittkopp@nyulangone.org

646-501-7733

Study Officials

• Jonathan D Newman

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: August 11, 2022
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)