Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure (APCIQ-BP)

Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure: the APCIQ-BP Trial

The main objective is to determine if in-home portable air cleaners provide persistent reductions in PM2.5 exposures and improvements in systolic blood pressure and biochemical parameters over 4-weeks in patients with metabolic syndrome residing in Qatar.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome; Hypertension, Systolic
• Intervention / Treatment: Device: Air cleaners with HEPA filter; Device: Air cleaners without HEPA filter

Detailed Description

Chronic cardio-metabolic diseases such as hypertension and diabetes contribute disproportionately to global morbidity and mortality and are increasing believed to have multiple environmental influences.

PM2.5 is the fifth leading risk factor for global mortality - largely due to cardiovascular disease (CVD). Reducing personal exposure to air pollution has shown promise in improving key cardiovascular risk factors (blood pressure and insulin resistance) in limited studies, but durability of these effects is not known. Personal air cleaners have been shown to decrease personal exposure to PM2.5 and reduce blood pressure in small studies and may serve as a pragmatic intervention in high-risk patients in whom air pollution is a strong contributor to cardiovascular health.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charbel Abi Khalil, MD; Phone Number: +974 4492 8484; Email: cha2022@qatar-med.cornell.edu

Study Locations

• Qatar
  • Doha, Qatar
    • Recruiting
    • Hamad Medical Corporation
    • Contact: Jassim Al-Suwaidi, MD; Phone Number: +974 4439 5354; Email: jalsuwaidi@hamad.qa
    • Principal Investigator: Charbel Abi Khalil, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Non-smokers (100% abstinence from use of any smoking or vaping product during the prior year)
• Age ≥18 and less than 60 years old
• Living in a single residence (home, apartment) located anywhere in Qatar

• Mild systolic hypertension: screening visit systolic BP 130 to 159 mm Hg (off treatment or taking ≤ 2 BP medications that have been stable without changes during prior 4 weeks) plus ≥ 2 more additional criteria for the metabolic syndrome:

  • Waist circumference ≥102 cm if male and ≥88 cm if female
  • Fasting triglycerides ≥150 mg/dL (or taking a triglyceride-lowering medication)
  • HDL-C ≤ 40 mg/dL if male and ≤ 50 mg/dL if female (or taking an HDL-raising medication),
  • Fasting glucose ≥100 mg/dL

Exclusion Criteria:

• Pregnancy (self-reported)
• Screening visit urine positive for cotinine (NicAlert >100 ng/mL)
• Living with an active smoker who smokes indoors (by self-report)
• High risk conditions that prohibit allowing home BP to be >130/80 mm Hg during the10-week trial including any cardiovascular disease (coronary artery disease, prior stroke, heart failure, peripheral arterial disease, aneurysm) or ≥ stage 3 kidney disease (estimated glomerular filtration rate < 60 ml/min)
• A medical condition placing the participant at risk from participation (per investigators)
• Expected overnight travel outside their residence during the study
• HEPA filter within the air conditioners of the residence (self-reported) or individual use of HEPA filter
• Unable to comprehend/sign an informed consent
• Lung disease requiring oxygen
• Cancer receiving treatment
• Screening visit: BP ≥160/100 mm Hg or fasting blood glucose ≥126 mg/dL and confirmed diabetes with follow-up HbA1c ≥6.5%. If glucose is elevated ≥126 mg/dL but HbA1c<6.5%, they could still participate.
• Medication changes in past 4 weeks. If participants are on medications for high BP or hyperlipidemia, they will need to have had stable therapy during prior 10 weeks with no planned changes during the study
• Left upper arm circumference >17 inches as this will make BP levels inaccurate with the home monitor used
• Acute illness or infectious symptoms within the prior 4 weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active mode; In home use of portable air cleaners with a High Efficiency Particulate Air (HEPA) filter for 4 weeks.	Device: Air cleaners with HEPA filter; PM 2.5 exposure reduction using in home portable air cleaners fitted with HEPA filters
Sham Comparator: Sham mode; In home use of portable air cleaners without a High Efficiency Particulate Air (HEPA) filter for 4 weeks.	Device: Air cleaners without HEPA filter; Simulation of PM 2.5 exposure reduction using in home portable air cleaners without HEPA filters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure	Mean change from baseline in systolic blood pressure	week 4, week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Glycemia	Mean change from baseline in fasting glycemia	week 4, week 10
Change in Insulin Resistance Index	Mean change from baseline in Insulin Resistance Index	week 4, week 10

Collaborators and Investigators

• Sponsor: Weill Cornell Medical College in Qatar
• Collaborators: Hamad Medical Corporation; Case Western Reserve University
• Investigators: Principal Investigator: Charbel Abi Khalil, MD, Weill Cornell Medical College in Qatar

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; metabolic syndrome; air pollution
• Additional Relevant MeSH Terms: Essential Hypertension; Vascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Isolated Systolic Hypertension; Hypertension; Cardiovascular Diseases; Metabolic Syndrome
• Other Study ID Numbers: 22-00009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after de-identification (test, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately after publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No