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

January 27, 2026 updated by: NYU Langone Health

Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 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
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Distance Walked
Time Frame: Baseline, 12 months
The distance in meters will be recorded during a 6-minute walk test (MWT)
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Systolic Blood Pressure (SBP)
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in Heart Rate
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in pro B-type natriuretic peptide (Pro-BNP) Levels
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in Number of Hospitalizations
Time Frame: Baseline, 12 months
Baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

  • Principal Investigator: Rajesh Vedanthan, MD, MPH, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

January 29, 2022

First Submitted That Met QC Criteria

January 29, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-00954
  • R01ES033222 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access upon reasonable request. Requests should be directed to rajesh.vedanthan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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