The PURI-HF (Air Purifiers on Heart Failure) Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HEPA Air Purifier 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. |
Other: AirOk Air Purifier
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.
|
| Placebo Comparator: EGAPA Air Purifier 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. |
Other: Placebo Air Filter
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.
|
Outcome Measures
Primary Outcome Measures
- Change in Distance Walked [Baseline, 12 months]
The distance in meters will be recorded during a 6-minute walk test (MWT)
Secondary Outcome Measures
- Change in Systolic Blood Pressure (SBP) [Baseline, 12 months]
- Change in Diastolic Blood Pressure (DBP) [Baseline, 12 months]
- Change in Heart Rate [Baseline, 12 months]
- Change in pro B-type natriuretic peptide (Pro-BNP) Levels [Baseline, 12 months]
- Change in Number of Hospitalizations [Baseline, 12 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adults ≥ 18 years of age diagnosed with HF with a reduced ejection fraction of ≤ 40% within the last six months in NYHA class II-IV.
Exclusion Criteria:
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listed for a cardiac transplant
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history of CRT device implantation in last 3 months
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on oxygen therapy
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with severe pulmonary disease
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participants unable to ambulate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre for Chronic Disease Control (CCDC) | Thiruvananthapuram | Kerala | India | |
| 2 | All India Institute of Medical Sciences (AIIMS) | Delhi | Punjab | India | |
| 3 | Public Health Foundation of India (PHFI) | Ludhiāna | Punjab | India |
Sponsors and Collaborators
- NYU Langone Health
- National Institute of Environmental Health Sciences (NIEHS)
Investigators
- Principal Investigator: Rajesh Vedanthan, MD, MPH, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-00954
- R01ES033222