Key Dates

Related Announcements

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Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform the scientific community that the National Heart, Lung, and Blood Institute (NHLBI) plans to fund a second examination of participants in the RURAL Heart and Lung Study. The examination is expected to begin approximately January-February 2027 with a targeted sample size for examination of approximately 4,000 participants. The exam is intended, in part, to serve as a platform for independently funded exam components via investigator-initiated grants or other independently funded projects to enrich the exam data collection with additional hypothesis-driven content. The research aims of such exam-related ancillary projects need not be limited to those within the mission of the NHLBI but must be consistent with and/or complement RURAL study objectives.

This Notice allows interested researchers sufficient time to develop their research hypotheses and designs; comply with any applicable cohort study-specific and NIH $500K requirements; submit and, if necessary, re-submit their grant applications; receive funding awards; and participate in exam planning and coordination prior to the exam start.

THIS IS NOT A NOTICE OF FUNDING OPPORTUNITY (NOFO). NO SOLICITATION FOR GRANT APPLICATIONS WILL BE ISSUED FOR THIS PURPOSE. APPLICANTS MUST USE EXISTING FUNDING OPPORTUNITY ANNOUNCEMENTS AS APPROPRIATE

Background

Enrollment of a targeted total of 4,600 participants into the initial, baseline exam of the RURAL Heart and Lung study began in late 2021 and will conclude approximately May 1, 2026. Eligible participants include those aged 25-64 years of age, and residing in one of the 10 targeted RURAL counties in Alabama, Mississippi, Louisiana, and Kentucky. To address potential limitations in the availability of traditional “brick-and-mortar” facilities in rural areas, RURAL utilizes a mobile exam unit (MEU) to enroll and examine participants. The MEU provides space for intake, phlebotomy and a laboratory, secure interview room, and a state-of-the-art computed tomography scanner. RURAL leverages an ecological paired design such that rural counties at high risk for cardiopulmonary outcomes are paired with counties at lower risk based on county level demographic profiles. Key components of the baseline exam (aka first exam) include: anthropometry, biospecimen collection, behavioral/medical/demographic assessments, gated cardiac CT, inspiratory and expiratory chest CT, pulmonary function testing, Echocardiography, and an mHealth component that includes a smartphone with an embedded RURAL app, a Fitbit, and suite of questionnaires to comprehensively characterize Social Determinants of Health (SDoH).

The NHLBI is publishing this guide notice to encourage peer-reviewed investigator-initiated research projects to provide innovative content suitable for an MEU setting and serve as a significant driver of the research agenda in the RURAL Heart and Lung study second exam.

Additional Information

This Notice is being released now to allow time for interested researchers to develop, submit, and potentially resubmit NIH grant applications to fund exam components addressing innovative research questions in the RURAL Heart and Lung Study.

Interested investigators are not required to be RURAL investigators, but they must submit and receive approval of a proposal per RURAL ancillary study policies. Ancillary study investigators are expected to work collaboratively with the RURAL investigators/ the RURAL Study Coordination Center, and follow all relevant RURAL policies and procedures. Ancillary study investigators are expected to comply with RURAL and NHLBI requirements for sharing of collected ancillary study data with the RURAL study and the scientific community as outlined in the NHLBI Data Freeze approach. Ancillary studies must adhere to permissible participant burden (as part of the core second exam and remote monitoring post-exam) as determined by the RURAL Study and the NHLBI.

Researchers desiring data for their analyses beyond what will be obtained via the core second exam components must plan and budget for the additional data collection in their grant applications in consultation with the RURAL Study Coordination Center. The planned, core components of the RURAL second examination include: reception and consent; update of demographic information, basic anthropometry, blood pressure, lifestyle factors, medical history, medications, social determinants of health, ECG, spirometry, cardiac and chest computed tomography (CT), and collection of blood and urine for analytes measured in real time and for storage in the RURAL Biorepository. Laboratory assays to be funded include: fasting glucose, HbA1c, lipid panel, urine creatinine and albumin. A mobile health infrastructure platform will also be supported. Collection of any additional data required to address an application's specific aims must be planned and budgeted for in the grant application, including consideration of participant compensation, data management and sharing costs, and logistical support for integration of new content into the planned examination.

Meritorious proposals in the following domains are encouraged:

• Environmental and structural factors impacting health in rural southeastern communities, including urban-rural comparative studies that engage multiple NHLBI cohorts
• Heart structure and function and markers of pre-clinical heart failure
• The intersection of infection and vaccine history and cardiopulmonary outcomes
• Biomarkers for assessing kidney function
• Factors associated with diabetes risk and progression
• Prevalence, correlates, and mediators of vascular function
• Cardiometabolic factors and cognitive function
• Occupational exposures and home air quality for understanding lung and heart health
• Innovative science regarding lifestyle and health behaviors
• Novel strategies for community engagement, particularly aimed at addressing health disparities in the rural South
• Incorporating data science and new technologies to drive scientific discovery

Timing for Submission of Grant Applications

Grant application submission deadlines are described at https://grants.nih.gov/grants/how-to-apply-application-guide/due-dates-and-submission-policies/due-dates.htm. 

Inquiries

Please direct all inquiries to:

Sean Coady, MA, MS
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]

Lindsay Pool, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Email: [email protected]