Cleaner Air for Better Cardiac Biomarkers

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05379400
• Other study ID #: 22-00045
• Status: Completed
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: August 24, 2023

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 24, 2023
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in circulating concentration of Tumor Necrosis Factor alpha (TNFa)	Circulating concentrations of TNFa will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis.	Baseline, Week 4
Secondary	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