Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure

NCT05903950 | Recruiting DMC

• 1 other identifier: 22-00009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Systolic; Metabolic Syndrome

Keywords

hypertension; metabolic syndrome; air pollution

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure

  Mean change from baseline in systolic blood pressure

  week 4, week 10

Secondary Outcomes (2)

• Change in Fasting Glycemia

  week 4, week 10

• Change in Insulin Resistance Index

  week 4, week 10

Study Arms (2)

Active mode

ACTIVE COMPARATOR

In home use of portable air cleaners with a High Efficiency Particulate Air (HEPA) filter for 4 weeks.

Device: Air cleaners with HEPA filter

Sham mode

SHAM COMPARATOR

In home use of portable air cleaners without a High Efficiency Particulate Air (HEPA) filter for 4 weeks.

Device: Air cleaners without HEPA filter

Interventions

Air cleaners with HEPA filter DEVICE

PM 2.5 exposure reduction using in home portable air cleaners fitted with HEPA filters

Active mode

Air cleaners without HEPA filter DEVICE

Simulation of PM 2.5 exposure reduction using in home portable air cleaners without HEPA filters.

Sham mode

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Cornell Medical College in Qatar: lead
• Hamad Medical Corporation: collaborator
• Case Western Reserve University: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

MeSH Terms

Conditions

Isolated Systolic Hypertension; Metabolic Syndrome; Hypertension

Condition Hierarchy (Ancestors)

Essential Hypertension; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Charbel Abi Khalil, MD

  Weill Cornell Medical College in Qatar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charbel Abi Khalil, MD

CONTACT

+974 4492 8484; cha2022@qatar-med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 15, 2023
• Study Start: November 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately after publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

QA (1)