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

Primary Purpose

Hypertension, Systolic, Metabolic Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Air cleaners with HEPA filter
Air cleaners without HEPA filter
Sponsored by
Weill Cornell Medical College in Qatar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension, Systolic focused on measuring hypertension, metabolic syndrome, air pollution

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hamad Medical CorporationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active mode

Sham mode

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Systolic Blood Pressure
Mean change from baseline in systolic blood pressure

Secondary Outcome Measures

Change in Fasting Glycemia
Mean change from baseline in fasting glycemia
Change in Insulin Resistance Index
Mean change from baseline in Insulin Resistance Index

Full Information

First Posted
June 5, 2023
Last Updated
June 18, 2023
Sponsor
Weill Cornell Medical College in Qatar
Collaborators
Hamad Medical Corporation, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT05903950
Brief Title
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Acronym
APCIQ-BP
Official Title
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure: the APCIQ-BP Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Cornell Medical College in Qatar
Collaborators
Hamad Medical Corporation, Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Systolic, Metabolic Syndrome
Keywords
hypertension, metabolic syndrome, air pollution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active mode
Arm Type
Active Comparator
Arm Description
In home use of portable air cleaners with a High Efficiency Particulate Air (HEPA) filter for 4 weeks.
Arm Title
Sham mode
Arm Type
Sham Comparator
Arm Description
In home use of portable air cleaners without a High Efficiency Particulate Air (HEPA) filter for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Air cleaners with HEPA filter
Intervention Description
PM 2.5 exposure reduction using in home portable air cleaners fitted with HEPA filters
Intervention Type
Device
Intervention Name(s)
Air cleaners without HEPA filter
Intervention Description
Simulation of PM 2.5 exposure reduction using in home portable air cleaners without HEPA filters.
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
Mean change from baseline in systolic blood pressure
Time Frame
week 4, week 10
Secondary Outcome Measure Information:
Title
Change in Fasting Glycemia
Description
Mean change from baseline in fasting glycemia
Time Frame
week 4, week 10
Title
Change in Insulin Resistance Index
Description
Mean change from baseline in Insulin Resistance Index
Time Frame
week 4, week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charbel Abi Khalil, MD
Phone
+974 4492 8484
Email
cha2022@qatar-med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charbel Abi Khalil, MD
Organizational Affiliation
Weill Cornell Medical College in Qatar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jassim Al-Suwaidi, MD
Phone
+974 4439 5354
Email
jalsuwaidi@hamad.qa
First Name & Middle Initial & Last Name & Degree
Charbel Abi Khalil, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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