Key Dates

Related Announcements

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-184 - NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-185 - Research Project Grant (Parent R01 Clinical Trial Not Allowed)

NOT-HL-20-015 - Notice of Change to NIEHS target FOAs for NOT-HL-20-788

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Environmental Health Sciences (NIEHS)

Purpose

Purpose

The purpose of this trans-NIH Notice of Special Interest (NOSI) is to inform potential applicants that the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Environmental Health Sciences (NIEHS) have special interest in applications aiming to investigate the impact of personal interventions to reduce exposure to particulate matter (PM) in air pollution on cardiovascular and pulmonary (cardiopulmonary) outcomes. This notice specifically encourages intervention studies or clinical trials that examine the efficacy of personal air pollution interventions to reduce the adverse cardiopulmonary effects of Particulate Matter (PM) <2.5 m in diameter (PM2.5) in high risk or vulnerable participants.

Background

Substantial evidence supports PM_2.5 as the fifth leading risk factor for global mortality, accounting for roughly 8.9 million deaths per year - 213,000 in North America alone. Short-term PM_2.5 exposure increases the risk for acute myocardial infarction, stroke, heart failure, arrhythmias (AF and ventricular ectopy), and/or sudden death. Chronic PM_2.5 exposure increases these risks to an even greater degree (roughly 10% per 10 g/m3) and effects may be even more pronounced in susceptible sub-populations such as older adults, lower socioeconomic status, and individuals with pre-existing conditions (e.g., diabetes mellitus, coronary artery disease, heart failure, asthma and COPD). With the rates of wildfires increasing, there is also growing concern of wildfire smoke exposure in the U.S. adversely impacting air quality and contributing to respiratory and cardiovascular disorders.

To assess the current state of the science on the potential benefits of reducing the impact of air pollution in high risk or susceptible populations, a trans-agency workshop was organized (https://www.nhlbi.nih.gov/events/2019/reducing-cardiopulmonary-impact-particulate-matter-air-pollution-high-risk-populations). Experts from academia, federal agencies in the areas of air pollution exposure assessment, epidemiology, cardiovascular, pulmonary medicine, clinical trials, building engineering and healthcare disparities who attended this two-day workshop recognized the need to support a focused research effort on preventing and reducing exposures among at-risk individuals at the personal level.

Personal level interventions are defined as approaches used to reduce an individual's PM_2.5 exposure (from indoor and outdoor sources) and commonly include indoor portable air cleaners (PACs) and facemasks (e.g., N95 respirators). A growing body of evidence suggests that personal interventions can reduce exposure to PM_2.5 and improve surrogate markers of cardiometabolic risk. However, while several strategies exist, the most relevant interventions feasibly implemented in large populations are understudied.

Research Objectives

This Trans-NIH partnership seeks to foster clinical trial/intervention research examining the efficacy of personal interventions to reduce PM_2.5 exposures and the associated benefits in cardiopulmonary outcomes. This NOSI specifically encourages studies focusing on mechanistic, subclinical outcomes, and if feasible, clinical outcomes, particularly in high risk populations.

Specific topics of research interest include, but are not limited to the following:

NHLBI

• Feasibility trials or other research designs that examine the efficacy and influence of use of personal interventions such as N95 respirators, high-efficiency home air filtration, or portable air cleaners (PAC) to reduce exposure to PM_2.5
  • Studies that compare the effectiveness of personal interventions
  • Studies that evaluate factors affecting adherence to the intervention, such as attributes of the study population, level of burden on participants, or methods to increase participant engagement
  • Studies that evaluate different approaches to implementing the intervention, e.g., single family housing compared to multi-family housing, area of use for an intervention, hours of use, season of use, duration of use
• Feasibility trials or clinical studies that investigate the influence of personal air pollution interventions in reducing mechanistic and surrogate endpoints, and related cardiopulmonary outcomes in high risk populations
• • Studies that focus on relevant intermediate endpoints that could inform the design of a future large clinical study
• • Studies that help define eligibility for subjects in a large clinical study
• Feasibility trials or clinical studies to investigate affordability and acceptability of personal intervention devices for sustained use in different at-risk populations, including racial and ethnic minority populations, and rural and low-SES communities

NIEHS

In addition to the research topics listed above, possible interests of the NIEHS include but are not limited to the following:

• Studies investigating the impact of an intervention on reduction in PM_2.5, ultrafine particles, or gaseous air pollutants
• Studies investigating the impact of an intervention on acute inflammatory markers, oxidative stress biomarkers, or biomarkers of exposure
• Studies evaluating the variable impact of an intervention in individuals with normal vs. pre-existing cardiopulmonary phenotypes
• Studies incorporating personal monitoring tools to assess the efficacy of intervention strategies
• Pilot studies exploring the impact of an intervention combined with exposure science tools or technologies
• Studies using an -omic approach to examine the efficacy of air pollution interventions with cardiopulmonary outcomes. (e.g., exposomic, metabolomic, epigenomic, genomic, GxE, etc.)

Application and Submission Information

This notice applies to due dates on or after October 5, 2020 and subsequent receipt dates through September 7, 2025. Submit applications for this initiative using the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.

NHLBI FOAs for this NOSI

NIEHS FOAs for this NOSI

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HL-20-788 in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with a program officer listed on this NOSI well in advance of the grant receipt date.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions

Scientific/Research Contact(s)

Lawrence J. Fine, MD, DrPH
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0305
Email: Lawrence.Fine@NIH.gov

Bonnie Joubert, MPH, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3276
Email: bonnie.joubert@nih.gov

Srikanth Nadadur, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3296
Email: nadadurs@niehs.nih.gov

Financial/Grants Management Contact(s)

Tammi Simpson
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0166
Email: simpsontl@mail.nih.gov