The PURI-HF (Air Purifiers on Heart Failure) Trial
Primary Purpose
Heart Failure
Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
AirOk Air Purifier
Placebo Air Filter
Sponsored by
About this trial
This is an interventional other trial for Heart Failure focused on measuring Indoor Air Purifier
Eligibility Criteria
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
Sites / Locations
- Centre for Chronic Disease Control (CCDC)
- All India Institute of Medical Sciences (AIIMS)
- Public Health Foundation of India (PHFI)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HEPA Air Purifier
EGAPA Air Purifier
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Distance Walked
The distance in meters will be recorded during a 6-minute walk test (MWT)
Secondary Outcome Measures
Change in Systolic Blood Pressure (SBP)
Change in Diastolic Blood Pressure (DBP)
Change in Heart Rate
Change in pro B-type natriuretic peptide (Pro-BNP) Levels
Change in Number of Hospitalizations
Full Information
NCT ID
NCT05230784
First Posted
January 29, 2022
Last Updated
June 28, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT05230784
Brief Title
The PURI-HF (Air Purifiers on Heart Failure) Trial
Official Title
Effectiveness of Indoor Air Purifiers on Heart Failure Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Indoor Air Purifier
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HEPA Air Purifier
Arm Type
Experimental
Arm 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.
Arm Title
EGAPA Air Purifier
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
AirOk Air Purifier
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Air Filter
Intervention Description
Participants in the placebo arm will receive an air purifier with only the EGAPA filter.
Primary Outcome Measure Information:
Title
Change in Distance Walked
Description
The distance in meters will be recorded during a 6-minute walk test (MWT)
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in Systolic Blood Pressure (SBP)
Time Frame
Baseline, 12 months
Title
Change in Diastolic Blood Pressure (DBP)
Time Frame
Baseline, 12 months
Title
Change in Heart Rate
Time Frame
Baseline, 12 months
Title
Change in pro B-type natriuretic peptide (Pro-BNP) Levels
Time Frame
Baseline, 12 months
Title
Change in Number of Hospitalizations
Time Frame
Baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajesh Vedanthan, MD, MPH
Phone
646-501-3890
Email
Rajesh.vedanthan@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Dickhaus
Phone
646-501-3663
Email
Julia.dickhaus@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Vedanthan, MD, MPH
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Chronic Disease Control (CCDC)
City
Thiruvananthapuram
State/Province
Kerala
Country
India
Facility Name
All India Institute of Medical Sciences (AIIMS)
City
Delhi
State/Province
Punjab
Country
India
Facility Name
Public Health Foundation of India (PHFI)
City
Ludhiāna
State/Province
Punjab
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
The PURI-HF (Air Purifiers on Heart Failure) Trial
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