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| ID | Type | Description | Link |
|---|---|---|---|
| R01ES033222 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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Indoor air pollution and fine mode particulate matter with an aerodynamic diameter smaller than 2.5 micrometers (PM2.5) is a major contributor to global morbidity and mortality, particularly due to cardiovascular disease. This project aims to demonstrate the efficacy, feasibility and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India. The findings from the project will add to existing knowledge of innovative and scalable strategies to improve environmental and cardiovascular health worldwide.
The overall objective of this study is to demonstrate the efficacy, feasibility, and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEPA Air Purifier | Experimental | Air purifier is installed in participants' households by the research team. Twice per year, participants will wear a GPS as well as a backpack containing a particulate matter 2.5 (PM2.5) personal exposure monitor for a 24-hour monitoring period. |
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| EGAPA Air Purifier | Placebo Comparator | Air purifier is installed in participants' households by the research team. Twice per year, participants will wear a GPS as well as a backpack containing a particulate matter 2.5 (PM2.5) personal exposure monitor for a 24-hour monitoring period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirOk Air Purifier | Other | The AirOk purifier nests on a locally developed patented technology that combines HEPA (grade H12) and a novel EGAPA (Effective Granular Adsorbent Particulate Arrestor) to reduce indoor air pollution. The HEPA filter removes all particulate matter up to 0.3 µm in aerodynamic diameter, and the dual stratified EGAPA filter removes other pollutants such as sulfur, nitrous oxide, carbon oxide, volatile organic compounds, allergens, and mold. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Distance Walked | The distance in meters will be recorded during a 6-minute walk test (MWT) | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) | Baseline, 12 months | |
| Change in Diastolic Blood Pressure (DBP) | Baseline, 12 months | |
| Change in Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Vedanthan, MD, MPH | Contact | 646-501-3890 | Rajesh.vedanthan@nyulangone.org | |
| Jessica Gjonaj | Contact | 646-501-3663 | Jessica.gjonaj@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Rajesh Vedanthan, MD, MPH | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Chronic Disease Control (CCDC) | Recruiting | Thiruvananthapuram | Kerala | India | ||
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to rajesh.vedanthan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Placebo Air Filter | Other | Participants in the placebo arm will receive an air purifier with only the EGAPA filter. |
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| Baseline, 12 months |
| Change in pro B-type natriuretic peptide (Pro-BNP) Levels | Baseline, 12 months |
| Change in Number of Hospitalizations | Baseline, 12 months |
| All India Institute of Medical Sciences (AIIMS) |
| Recruiting |
| Delhi |
| Punjab |
| India |
| Public Health Foundation of India (PHFI) | Recruiting | Ludhiana | Punjab | India |