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

NCT ID: NCT05230784

Last Updated: 2026-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2028-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AirOk Air Purifier

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo Air Filter

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Placebo Air Filter

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajesh Vedanthan, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Centre for Chronic Disease Control (CCDC)

Thiruvananthapuram, Kerala, India

Site Status RECRUITING

All India Institute of Medical Sciences (AIIMS)

Delhi, Punjab, India

Site Status RECRUITING

Public Health Foundation of India (PHFI)

Ludhiana, Punjab, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Rajesh Vedanthan, MD, MPH

Role: CONTACT

646-501-3890

Jessica Gjonaj

Role: CONTACT

646-501-3663

Other Identifiers

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R01ES033222

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-00954

Identifier Type: -

Identifier Source: org_study_id

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