The PURI-HF (Air Purifiers on Heart Failure) Trial

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes

Conditions
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Heart Failure

Intervention / Treatment
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* Other: AirOk Air Purifier
* Other: Placebo Air Filter


Participation Criteria
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Eligibility Criteria
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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: listed for a cardiac transplant history of CRT device implantation in last 3 months on oxygen therapy with severe pulmonary disease participants unable to ambulate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEPA Air Purifier<br>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<br>* 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.<br>|
| Placebo Comparator: EGAPA Air Purifier<br>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<br>* Participants in the placebo arm will receive an air purifier with only the EGAPA filter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Baseline, 12 months | 
| Change in pro B-type natriuretic peptide (Pro-BNP) Levels |  | Baseline, 12 months | 
| Change in Number of Hospitalizations |  | Baseline, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indoor Air Purifier