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

Sponsor

Weill Cornell Medical College in Qatar (Other)

Overall Status

Recruiting

CT.gov ID

NCT05903950

Collaborator

Hamad Medical Corporation (Industry), Case Western Reserve University (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Systolic Metabolic Syndrome	Device: Air cleaners with HEPA filter Device: Air cleaners without HEPA filter	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Systolic Blood Pressure [week 4, week 10]
Mean change from baseline in systolic blood pressure

Secondary Outcome Measures

Change in Fasting Glycemia [week 4, week 10]
Mean change from baseline in fasting glycemia
Change in Insulin Resistance Index [week 4, week 10]
Mean change from baseline in Insulin Resistance Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.