Heart Failure
Conditions
Keywords
Indoor Air Purifier
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.
Interventions
OTHERAirOk 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.
OTHERPlacebo Air Filter
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.
Sponsors
NYU Langone Health
National Institute of Environmental Health Sciences (NIEHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Distance Walked | Baseline, 12 months | The distance in meters will be recorded during a 6-minute walk test (MWT) |
Secondary
| Measure | 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 |
Countries
India
Contacts
CONTACTRajesh Vedanthan, MD, MPH
CONTACTJessica Gjonaj
PRINCIPAL_INVESTIGATORRajesh Vedanthan, MD, MPH
NYU Langone Health
Outcome results
None listed