Clinical trial NCT05379400: Cleaner Air for Better Cardiac Biomarkers
Official title: Cardiometabolic Biomarker Improvements Associated With Reduction in Air Pollution Exposure Via Home Air Filtration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα)
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan D Newman
role: PRINCIPAL_INVESTIGATOR
References: