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NCT Number: NCT05230784

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

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Chronic Disease Control (CCDC), Thiruvananthapuram, Kerala, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo Air Filter

Other

Participants in the placebo arm will receive an air purifier with only the EGAPA filter.

Primary outcomes

  1. Change in Distance Walked

    Time frame: Baseline, 12 months

    The distance in meters will be recorded during a 6-minute walk test (MWT)

Secondary outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: Baseline, 12 months

  2. Change in Diastolic Blood Pressure (DBP)

    Time frame: Baseline, 12 months

  3. Change in Heart Rate

    Time frame: Baseline, 12 months

  4. Change in pro B-type natriuretic peptide (Pro-BNP) Levels

    Time frame: Baseline, 12 months

  5. Change in Number of Hospitalizations

    Time frame: Baseline, 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Gjonaj

CONTACT

[email protected]

646-501-3663

Rajesh Vedanthan, MD, MPH

CONTACT

[email protected]

646-501-3890

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 9, 2022
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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