The PURI-HF (Air Purifiers on Heart Failure) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AirOk Air Purifier, Placebo Air Filter.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
Overview
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
- 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. - Other Placebo Air Filter
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.
Primary outcome measures
- Change in Distance Walked [Time frame: Baseline, 12 months]
Secondary outcome measures (5)
- Change in Systolic Blood Pressure (SBP) [Time frame: Baseline, 12 months]
- Change in Diastolic Blood Pressure (DBP) [Time frame: Baseline, 12 months]
- Change in Heart Rate [Time frame: Baseline, 12 months]
- Change in pro B-type natriuretic peptide (Pro-BNP) Levels [Time frame: Baseline, 12 months]
- Change in Number of Hospitalizations [Time frame: Baseline, 12 months]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
India · 3 centers
- Centre for Chronic Disease Control (CCDC) — Thiruvananthapuram
- All India Institute of Medical Sciences (AIIMS) — Delhi
- Public Health Foundation of India (PHFI) — Ludhiana
Identifiers
NCT: NCT05230784 · 21-00954 · R01ES033222