Heart FailureNCT05230784
The PURI-HF (Air Purifiers on Heart Failure) Trial
A study testing AirOk Air Purifier in people with Heart Failure, run by NYU Langone Health at 3 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AirOk Air Purifier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 3 sitesIndia
- Study dates
- 6 Mar 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
All India Institute of Medical Sciences (AIIMS)
Delhi, Punjab
- Recruiting
Public Health Foundation of India (PHFI)
Ludhiana, Punjab
- Recruiting
Centre for Chronic Disease Control (CCDC)
Thiruvananthapuram, Kerala
About this study
Official title: Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
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
- Being tested
- AirOk Air Purifier, Placebo Air Filter
- Keywords
- Indoor Air Purifier
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirOk Air PurifierOther
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 FilterOther
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo Air Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Distance Walked
The distance in meters will be recorded during a 6-minute walk test (MWT)
Measured: Baseline, 12 months
Secondary outcomes (5)
Change in Systolic Blood Pressure (SBP)
Measured: Baseline, 12 months
Change in Diastolic Blood Pressure (DBP)
Measured: Baseline, 12 months
Change in Heart Rate
Measured: Baseline, 12 months
Change in pro B-type natriuretic peptide (Pro-BNP) Levels
Measured: Baseline, 12 months
Change in Number of Hospitalizations
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start6 Mar 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Rajesh Vedanthan, MD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230784
- Sponsor's protocol ID
- 21-00954
- Other IDs
- R01ES033222
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
- ClinicalTrials.gov ID
- NCT05230784
- Acronym / sponsor ID
- 21-00954
- Conditions
- Heart Failure
- Keywords
- Indoor Air Purifier
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEPA Air Purifier | Experimental | Other: AirOk Air PurifierAir 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. |
| EGAPA Air Purifier | Placebo comparator | Other: Placebo Air FilterAir 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirOk Air PurifierThe 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. | Other | HEPA Air Purifier |
| Placebo Air FilterParticipants in the placebo arm will receive an air purifier with only the EGAPA filter. | Other | EGAPA Air Purifier |
Primary outcome
Change in Distance Walked
Time frame: Baseline, 12 months
The distance in meters will be recorded during a 6-minute walk test (MWT)
5 secondary outcomes
Change in Systolic Blood Pressure (SBP)
Time frame: Baseline, 12 months
Change in Diastolic Blood Pressure (DBP)
Time frame: Baseline, 12 months
Change in Heart Rate
Time frame: Baseline, 12 months
Change in pro B-type natriuretic peptide (Pro-BNP) Levels
Time frame: Baseline, 12 months
Change in Number of Hospitalizations
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajesh Vedanthan, MD, MPH principal investigator
NYU Langone Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AirOk Air Purifier in people with Heart Failure, run by NYU Langone Health at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Vedanthan, MD, MPH (646-501-3890, Rajesh.vedanthan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distance Walked (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.