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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Placebo Air Filter; Other: AirOk Air Purifier

• Registration Number: NCT05230784
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-29
• Study First Submitted QC: 2022-01-29
• Study First Posted: 2022-02-09
• Study Start: 2024-03-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGAPA Air Purifier	Placebo Air Filter	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.
HEPA Air Purifier	AirOk 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.

Primary Outcome Measures

Name	Time	Method
Change in Distance Walked	Baseline, 12 months	The distance in meters will be recorded during a 6-minute walk test (MWT)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, Punjab, India

Centre for Chronic Disease Control (CCDC); 🇮🇳 Thiruvananthapuram, Kerala, India

Public Health Foundation of India (PHFI); 🇮🇳 Ludhiāna, Punjab, India