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

NCT05230784 | Recruiting

• 2 other identifiers: 21-00954R01ES033222
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Heart Failure

Keywords

Indoor Air Purifier

Outcome Measures

Primary Outcomes (1)

• Change in Distance Walked

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

  Baseline, 12 months

Secondary Outcomes (5)

• Change in Systolic Blood Pressure (SBP)

  Baseline, 12 months

• Change in Diastolic Blood Pressure (DBP)

  Baseline, 12 months

• Change in Heart Rate

  Baseline, 12 months

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

  Baseline, 12 months

• Change in Number of Hospitalizations

  Baseline, 12 months

Study Arms (2)

HEPA Air Purifier

EXPERIMENTAL

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

EGAPA Air Purifier

PLACEBO COMPARATOR

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

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.

HEPA Air Purifier

Placebo Air Filter OTHER

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

EGAPA Air Purifier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (3)

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rajesh Vedanthan, MD, MPH

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajesh Vedanthan, MD, MPH

CONTACT

646-501-3890; Rajesh.vedanthan@nyulangone.org

Jessica Gjonaj

CONTACT

646-501-3663; Jessica.gjonaj@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2022
• First Posted: February 9, 2022
• Study Start: March 6, 2024
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

IN (3)