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

NYU Langone Health

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: AirOk Air Purifier; Other: Placebo Air Filter

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05230784

21-00954

R01ES033222 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

255 participants in 2 patient groups, including a placebo group

HEPA Air Purifier

Experimental group

Description:

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.

Treatment:

Other: AirOk Air Purifier

EGAPA Air Purifier

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo Air Filter