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RecruitingNCT05230784Updated Jan 29, 2026

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

An interventional study of AirOk Air Purifier and Placebo Air Filter in Heart Failure, sponsored by NYU Langone Health. Recruiting at 3 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
255
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Indoor Air Purifier
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 255 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
255 participants (estimated)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Change in Distance Walked

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

    Time frame: Baseline, 12 months

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

07

Study locations

3 of 3 sites recruiting
  • Centre for Chronic Disease Control (CCDC)
    Thiruvananthapuram, Kerala, India
    Recruiting
  • All India Institute of Medical Sciences (AIIMS)
    Delhi, Punjab, India
    Recruiting
  • Public Health Foundation of India (PHFI)
    Ludhiana, Punjab, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05230784
Lead sponsor
NYU Langone Health
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Sponsor
First posted
Feb 9, 2022
Start date
Mar 6, 2024
Primary completion
Feb 29, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Jan 29, 2026

Study contacts

Rajesh Vedanthan, MD, MPH
Contact
Rajesh.vedanthan@nyulangone.org
646-501-3890
Jessica Gjonaj
Contact
Jessica.gjonaj@nyulangone.org
646-501-3663
Rajesh Vedanthan, MD, MPH
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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