Reducing Air Pollution to Lower Blood Pressure

NCT04908917 | Unknown DMC

• 1 other identifier: IRB-21-05-3595
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fine particulate matter \<2.5 μm (PM2.5) air pollution is the fifth leading risk factor for global mortality. Mitigating the clinically significant blood pressure (BP) elevation from air pollution by reducing PM2.5 exposure will likely contribute to the reduction in cardiovascular disease-related mortality. Twin epidemics of air pollution and high BP converge in underserved urban communities (i.e., Detroit) and warrant immediate attention. Prior studies with short duration (a few days) showed indoor portable air cleaners (PACs) are a novel approach to reduce the health burden of both high BP and PM2.5. Trials over several weeks employing remote technologies with a large sample size of patients residing in their own homes in vulnerable urban communities are needed to demonstrate if the BP-reduction from PAC usage is sustainable in real-world settings. The investigators' specific aims are to 1) determine if compared to sham, active PAC use during 3 weeks can provide sustained reductions in home BP levels by reducing personal-level PM2.5 air pollution exposures in patients with mild high BP residing in vulnerable disadvantaged communities across Detroit and 2) explore clinical markers (e.g., age, sex, body mass index) that predict BP-responses to PAC intervention to better target at-risk populations in larger-scale trials and future real-world clinical settings. A randomized, double-blind, sham-controlled parallel limb trial of overnight bedroom PAC use versus sham with 200 Detroit community individuals with mild high BP will be conducted. Continuous bedroom PM2.5 levels and home BP will be measured throughout 28 days. PAC will be used in the bedroom before bedtime on the 7th day continuously for 21 days. The reduction of systolic BP (SBP) will be calculated for both the intervention and control groups and the significance will be compared using mixed-effects modeling with repeated measurements of SBP as the dependent variable and group (active vs sham PAC use) as the independent variable with a fixed-effect. Linear multiple regression modeling with SBP as the dependent variable and participant-level characteristics including body mass index, waist circumference, race, ethnicity, or sex as predictors will be explored. This study is expected to demonstrate a significant sustainable reduction in home SBP for active PAC vs sham use in this population with mildly high BP.

Conditions

Mild Hypertension; Air Pollution Exposure

Outcome Measures

Primary Outcomes (1)

• Blood pressure change measured by blood pressure meter

  Home systolic and diastolic blood pressures will be measured using a self-administered blood pressure meter before (7 days) and during (21 days) the use of a portable air cleaner and compared between before and during use to see if blood pressures will be reduced during the air cleaner use phase, and between the intervention and control groups to see if there is a difference in blood pressure reduction between the two groups.

  28 days (Day 1 to Day 28 of the 4-week study).

Secondary Outcomes (2)

• Demographaic characteristics measured by a questionnaire

  One-time measurement at baseline (Day 1 to Day 7)

• Body mass index (BMI)

  One-time measurement (Day 1 to Day 7)

Study Arms (2)

PAC with HEPA

EXPERIMENTAL

Intervention group (N=100) to use a portable air cleaner (with a HEPA filter in PAC)

Device: Portable Air Cleaner with a HEPA Filter

PAC without HEPA

SHAM COMPARATOR

control group (N=100) with a sham portable air cleaner (no HEPA filter in PAC)

Device: Portable Air Cleaner without a HEPA Filter

Interventions

Portable Air Cleaner with a HEPA Filter DEVICE

A novel intervention using a portable air cleaner with HEPA filter to treat mildly high BP to potentially reduce the cardiovascular effects of PM2.5. Leave the PAC running with the HEPA filter installed on the highest setting during sleeping periods in the room in which the participant sleeps.

PAC with HEPA

Portable Air Cleaner without a HEPA Filter DEVICE

Leave the PAC running without a HEPA filter installed on the highest setting during sleeping periods in the room in which the participant sleeps.

Also known as: Control

PAC without HEPA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported nonsmokers (for at least last year)
• Has own smartphone
• Systolic BP (SBP) at 120-145 mmHg
• Diastolic blood pressure (DBP) \<95 mmHg
• Has history of hypertension with ≤ 3 medications and stable without change in past 3 months
• If medications are used, there should be no change in dosage during the 28-day study period.

You may not qualify if:

• Living with an active smoker who smokes indoors
• Left upper arm circumference \>17 inches (measured by tape measure upon recruitment as needed as it makes the home BP device inaccurate)
• Pregnant
• Unable/unwilling to consent
• Established cardiovascular disease (CVD)
• Stage IV clinical kidney disease (CKD)
• Clear barrier to technology use (e.g., visual or hearing impairment)
• Lung disease requiring oxygen
• Cancer receiving treatment
• Diabetes
• COVID-19 infections
• Any condition where the investigators believe the risk of a mildly high BP above 130/80 mmHg may pose risk to the patient during the 28-day period of the study including but not limited to aortic aneurysms

Sponsors & Collaborators

• Wayne State University: lead

Related Publications (20)

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• Cohen AJ, Brauer M, Burnett R, Anderson HR, Frostad J, Estep K, Balakrishnan K, Brunekreef B, Dandona L, Dandona R, Feigin V, Freedman G, Hubbell B, Jobling A, Kan H, Knibbs L, Liu Y, Martin R, Morawska L, Pope CA 3rd, Shin H, Straif K, Shaddick G, Thomas M, van Dingenen R, van Donkelaar A, Vos T, Murray CJL, Forouzanfar MH. Estimates and 25-year trends of the global burden of disease attributable to ambient air pollution: an analysis of data from the Global Burden of Diseases Study 2015. Lancet. 2017 May 13;389(10082):1907-1918. doi: 10.1016/S0140-6736(17)30505-6. Epub 2017 Apr 10.

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• Newby DE, Mannucci PM, Tell GS, Baccarelli AA, Brook RD, Donaldson K, Forastiere F, Franchini M, Franco OH, Graham I, Hoek G, Hoffmann B, Hoylaerts MF, Kunzli N, Mills N, Pekkanen J, Peters A, Piepoli MF, Rajagopalan S, Storey RF; ESC Working Group on Thrombosis, European Association for Cardiovascular Prevention and Rehabilitation; ESC Heart Failure Association. Expert position paper on air pollution and cardiovascular disease. Eur Heart J. 2015 Jan 7;36(2):83-93b. doi: 10.1093/eurheartj/ehu458. Epub 2014 Dec 9. No abstract available.

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• Rajagopalan S, Al-Kindi SG, Brook RD. Air Pollution and Cardiovascular Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2018 Oct 23;72(17):2054-2070. doi: 10.1016/j.jacc.2018.07.099.

  PMID: 30336830 RESULT

• Brook RD, Newby DE, Rajagopalan S. Air Pollution and Cardiometabolic Disease: An Update and Call for Clinical Trials. Am J Hypertens. 2017 Dec 8;31(1):1-10. doi: 10.1093/ajh/hpx109.

  PMID: 28655143 RESULT

• Bevan GH, Al-Kindi SG, Brook RD, Munzel T, Rajagopalan S. Ambient Air Pollution and Atherosclerosis: Insights Into Dose, Time, and Mechanisms. Arterioscler Thromb Vasc Biol. 2021 Feb;41(2):628-637. doi: 10.1161/ATVBAHA.120.315219. Epub 2020 Dec 17.

  PMID: 33327745 RESULT

• Giorgini P, Di Giosia P, Grassi D, Rubenfire M, Brook RD, Ferri C. Air Pollution Exposure and Blood Pressure: An Updated Review of the Literature. Curr Pharm Des. 2016;22(1):28-51. doi: 10.2174/1381612822666151109111712.

  PMID: 26548310 RESULT

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  PMID: 27245182 RESULT

• Liang R, Zhang B, Zhao X, Ruan Y, Lian H, Fan Z. Effect of exposure to PM2.5 on blood pressure: a systematic review and meta-analysis. J Hypertens. 2014 Nov;32(11):2130-40; discussion 2141. doi: 10.1097/HJH.0000000000000342.

  PMID: 25250520 RESULT

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  PMID: 29331891 RESULT

• Dvonch JT, Kannan S, Schulz AJ, Keeler GJ, Mentz G, House J, Benjamin A, Max P, Bard RL, Brook RD. Acute effects of ambient particulate matter on blood pressure: differential effects across urban communities. Hypertension. 2009 May;53(5):853-9. doi: 10.1161/HYPERTENSIONAHA.108.123877. Epub 2009 Mar 9.

  PMID: 19273743 RESULT

• Brook RD, Bard RL, Burnett RT, Shin HH, Vette A, Croghan C, Phillips M, Rodes C, Thornburg J, Williams R. Differences in blood pressure and vascular responses associated with ambient fine particulate matter exposures measured at the personal versus community level. Occup Environ Med. 2011 Mar;68(3):224-30. doi: 10.1136/oem.2009.053991. Epub 2010 Oct 8.

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  PMID: 26381985 RESULT

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available.

  PMID: 29133356 RESULT

• Hajat A, Allison M, Diez-Roux AV, Jenny NS, Jorgensen NW, Szpiro AA, Vedal S, Kaufman JD. Long-term exposure to air pollution and markers of inflammation, coagulation, and endothelial activation: a repeat-measures analysis in the Multi-Ethnic Study of Atherosclerosis (MESA). Epidemiology. 2015 May;26(3):310-20. doi: 10.1097/EDE.0000000000000267.

  PMID: 25710246 RESULT

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• Martenies SE, Milando CW, Williams GO, Batterman SA. Disease and Health Inequalities Attributable to Air Pollutant Exposure in Detroit, Michigan. Int J Environ Res Public Health. 2017 Oct 19;14(10):1243. doi: 10.3390/ijerph14101243.

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• Walzer D, Gordon T, Thorpe L, Thurston G, Xia Y, Zhong H, Roberts TR, Hochman JS, Newman JD. Effects of Home Particulate Air Filtration on Blood Pressure: A Systematic Review. Hypertension. 2020 Jul;76(1):44-50. doi: 10.1161/HYPERTENSIONAHA.119.14456. Epub 2020 Jun 1.

  PMID: 32475316 RESULT

• Morishita M, Adar SD, D'Souza J, Ziemba RA, Bard RL, Spino C, Brook RD. Effect of Portable Air Filtration Systems on Personal Exposure to Fine Particulate Matter and Blood Pressure Among Residents in a Low-Income Senior Facility: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1350-1357. doi: 10.1001/jamainternmed.2018.3308.

  PMID: 30208394 RESULT

Study Officials

• Youcheng Liu, MD, ScD, MS, MPH

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youcheng Liu, MD, ScD, MS, MPH

CONTACT

2817958000; gn9147@wayne.edu

Jazmine L Mui-Blackmon, BS, MPH

CONTACT

2483427037; Jazmine.Muib@wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Once a participant is recruited, an identification number in a sequence number (001, 002, 003, etc.) will be assigned to him or her. A simple randomization will be performed by the unblind study Biostatistician with random block sizes of 4 and 6 to allocate recruited participants into the intervention group (N=100, 50% allocation rate, PAC use with HEPA filter) and control group (N=100, allocation rate 50%, PAC use without HEPA filter).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: This study is designed as a randomized, double-blind, sham-controlled parallel limb clinical trial. Two-hundred participants will be recruited and randomly allocated into the intervention group (N=100) to use a PAC with a HEPA filter in the bedroom and the control group (N=100) with a sham PAC (no HEPA filter inside the container).

Study Record Dates

• First Submitted: May 22, 2021
• First Posted: June 1, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share