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

Heart Failure Clinical Trial

Official title:

Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05230784
• Other study ID #: 21-00954
• Secondary ID: R01ES033222
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Rajesh Vedanthan, MD, MPH
• Phone: 646-501-3890
• Email: Rajesh.vedanthan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences (AIIMS)	Delhi	Punjab
India	Public Health Foundation of India (PHFI)	Ludhiana	Punjab
India	Centre for Chronic Disease Control (CCDC)	Thiruvananthapuram	Kerala

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Distance Walked	The distance in meters will be recorded during a 6-minute walk test (MWT)	Baseline, 12 months
Secondary	Change in Systolic Blood Pressure (SBP)		Baseline, 12 months
Secondary	Change in Diastolic Blood Pressure (DBP)		Baseline, 12 months
Secondary	Change in Heart Rate		Baseline, 12 months
Secondary	Change in pro B-type natriuretic peptide (Pro-BNP) Levels		Baseline, 12 months
Secondary	Change in Number of Hospitalizations		Baseline, 12 months