Cardiovascular Diseases
Conditions
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.
Interventions
OTHERPortable 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.
OTHERSham 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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) | Baseline, Week 4 | Circulating concentrations of TNFα will be measured using the Olink Explore 384 Cardiometabolic panel for this a priori specified analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration | Baseline, Week 4 | Commercially available Particulate Matter (PM) monitors will record indoor PM2.5 concentrations using dual (backup) sensors, which store measurements on internal SD cards |
Countries
United States
Participant flow
Pre-assignment details
48 participants were enrolled, n=2 did not start the study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 22 |
| 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.
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. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Portable Air Cleaner (PAC) Group | Total | Sham Portable Air Cleaner (PAC) Group |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 12.8 | 58.6 years STANDARD_DEVIATION 11.8 | 57.8 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 20 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 18 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) White | 8 Participants | 18 Participants | 10 Participants |
| Region of Enrollment United States | 22 participants | 44 participants | 22 participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
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.
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portable Air Cleaner (PAC) Group | Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) | -1.03 percent change | Standard Deviation 8.35 |
| Sham Portable Air Cleaner (PAC) Group | Percent Change in Circulating Concentration of Tumor Necrosis Factor Alpha (TNFα) | 2 percent change | Standard Deviation 3.69 |
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
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Portable Air Cleaner (PAC) Group | Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration | 2.698 micrograms per cubic meter air (μ/m3) | Standard Deviation 2.483 |
| Sham Portable Air Cleaner (PAC) Group | Change in Indoor Particulate Matter < 2.5 um in Diameter (PM2.5) Concentration | 11.751 micrograms per cubic meter air (μ/m3) | Standard Deviation 20.93 |