National Heart, Lung, and Blood Advisory Council October 2021 Meeting Summary

DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

MEETING SUMMARY OF THE NATIONAL HEART, LUNG, AND BLOOD ADVISORY COUNCIL

October 26, 2021

The 295th meeting of the National Heart, Lung, and Blood Advisory Council (NHLBAC) convened virtually on Tuesday, October 26, 2021. The Council meeting began with a closed session that started at 10:05 a.m. and ended at 11:32 a.m. The open session reconvened from 11:52 a.m. and ended at to 2:32 p.m. Dr. Gary H. Gibbons, Director of NHLBI, presided as chair.

NHLBAC Members Attending

Victoria L. Bautch, Ph.D.
Kirsten Bibbins-Domingo, M.D., Ph.D.
Mercedes R. Carnethon, Ph.D.
Jennifer E. DeVoe, D.Phil., M.D.
Grace Anne Dorney Koppel, J.D.
Martha U. Gillette, Ph.D.
Garth Graham, M.D., M.P.H.
Tina V. Hartert, M.D., Ph.D.
David H. Ingbar, M.D.
Monica Kraft, M.D.
Kiran Musunuru, M.D., Ph.D.
Edward E. Morrisey, Ph.D.
Mohandas Narla, D.Sc.
Richard S Schofield, M.D. (Ex Officio)
Dean Sheppard, M.D.
Kevin L. Thomas, M.D.
Andrew S. Weyrich, Ph.D.
Zachariah P. Zachariah, M.D.

Members of the Public Attending

The total number watching online was reported by NIH Videocast to 301..

NHLBI Employees Attending

Several NHLBI staff members were in attendance via Zoom.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosures under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended.

REVIEW OF APPLICATIONS 

The session included a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions, or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect. The Council considered and recommended 3,261 applications requesting $7,686,955,970.00 in total costs. For the record, it is noted that secondary applications were also considered en bloc.

OPEN SESSION

I. CALL TO ORDER

Dr. Gary H. Gibbons, Director of the National Heart, Lung, and Blood Institute (NHLBI), called the meeting to order at 11:52 A.M. He welcomed Council members, NHLBI staff, and public attendees to the Open Session of the meeting.

II. ADMINISTRATIVE ANNOUNCEMENTS

Dr. Laura K. Moen (Director, Division of Extramural Research Activities, NHLBI) noted that the meeting will be publicly broadcast and archived on videocast. She reviewed the agenda.

III. REPORT OF THE DIRECTOR

Dr. Gibbons began by expressing his gratitude to the Council members whose terms were ending: Drs. Graham, Koppel, Kraft, Sheppard, and Weyrich. He highlighted each of their unique strengths and perspectives that they had provided to the Council. Dr. Gibbons then welcomed the new Council members: Drs. Bautch, Bibbins-Domingo, Carnethon, Hartert, and Morrisey—saying that he looks forward to their active engagement and thanking them for sharing their time and talent.

Accountable Stewardship. Dr. Gibbons updated the NHLBAC on NHLBI’s investments for fiscal year (FY) 2021 and funding prospects for FY 2022. Under the current continuing resolution, NHLBI’s appropriations are aligned with those of FY 2021. Early indications are that NHLBI’s FY 2022 budget may expand at a rate above inflation through both increased direct funding and participation in trans-NIH initiatives on maternal health, health disparities, the Advanced Research Projects Agency for Health (ARPA-H), and climate change health.

Despite fiscal challenges in FY 2021, NHLBI was able to align spending with its priorities. Overall funding success rates in FY 2021 were slightly lower than in FY 2020, but NHLBI was able to maintain its funding commitments to early-stage investigators, including cost extensions to K awardees in response to COVID-19. An outcome of the combined NHLBAC meeting with invited external experts in September 2021 was Council support and consequent rededication of NHLBI efforts to provide new opportunities for the next generation of investigators. Closing the funding gap between the K award and first R01 award is a key priority that the K-R03 mechanism appears to address. Also, the R56 bridge award is facilitating success in the transition of early-stage investigators to their first R01 award.

Advancing Scientific Priorities. Dr. Gibbons highlighted a specific area of the NHLBI mission which has been the subject of recent focused efforts. The initiative to improve maternal health through a multipronged approach intersects with NHLBI’s mission and prioritization of health disparities. Racial and ethnic disparities in morbidity and mortality among pregnant women persist. Morbidity and mortality also have increased as a result of increased maternal age. These statistics are highly relevant to NHLBI because of the high prevalence of hypertension, thrombotic, and bleeding orders in pregnancy, as well as peripartum cardiomyopathy. These adverse outcomes lead to increased cardiovascular risk to women that extends past their reproductive years, making pregnancy an important point for intervention. He noted that:

• Racial/ethnic disparities in women’s health must be addressed. Differences in maternal age, obesity, and family diabetes history manifest as heterogeneity among subgroups in gestational diabetes. Racial/ethnic disparities in sleep disorders also exist in pregnancy and are drivers of cardiovascular disease. NHLBI is committed to the challenge of characterizing heterogeneity in heart, lung, blood, and sleep disorders across racial/ethnic groups and subgroups.
• Pregnancy is equivalent to a stress test that reveals the long-term risk of heart disease. Common risk factors for adverse pregnancy outcomes and heart disease overlap. Rates of comorbidities in pregnancy are increasing. Current data show that up to 10 percent of pregnancies are complicated by hypertension.
• NHLBI is testing novel interventions on sleep-disordered breathing to reduce adverse pregnancy outcomes and cardiovascular disease risk. Recruitment is underway for a clinical trial to characterize sleep apnea during pregnancy and evaluate the interventions of sleep counseling and continuous positive airway pressure (CPAP) machines. The trial will examine the effects of these interventions on hypertension in pregnancy.

Dr. Gibbons explained that NHLBI is committed to a community-centered, multilevel approach to reducing health disparities in maternal mortality. Drivers of health disparities relate to individual characteristics and social determinants of health. Environmental and social factors are critical determinants of health in pregnancy and across diseases and conditions.

He pointed out that a key result of the Community Engagement Alliance (CEAL) against COVID-19 disparities was the critical importance of community engagement. CEAL established partnerships with the community, empowered them with information, and accelerated community benefits and uptakes. To sustain this lesson in maternal health, the Maternal Health Community Implementation Project (CIP) has formed multilevel partnerships on several high-risk communities to improve maternal health outcomes and advance health equity.

IV. THE NATIONAL CENTER ON SLEEP DISORDERS RESEARCH: FOSTERING SLEEP AND CIRCADIAN RESEARCH TO ADVANCE MEDICINE AND PUBLIC HEALTH FOR ALL

Dr. Marishka K. Brown (Director, NCSDR, NHLBI) provided an overview of NCSDR’s legislative origin, its charge, and the NIH Sleep Research Plan revision. The formation of NCSDR was congressionally mandated in 1993, and authorizing legislation outlined its charge, which includes conducting research, coordinating activities with other government agencies, and developing a research plan.

Dr. Brown noted that sleep and circadian research is supported across NIH, and funding has been increasing steadily. The exponential growth in the field of sleep disorders over the past few years has made it critical to reassess and update research opportunities and recommendations in a new Sleep Research Plan. NCSDR research has three broad mission areas: (1) regulation of sleep and sleep disorders, (2) sleep-disordered breathing, and (3) how the brain controls breathing. The Center’s coordinating activities extend across NIH and the federal government. Ideas are exchanged across NIH at meetings of the Sleep Disorders Research Advisory Board (SDRAB). Since NCSDR’s inception, three research plans were developed and implemented in 1996, 2003, and 2011. A highlight in sleep research was the awarding of the 2017 Nobel Prize in Physiology or Medicine for discoveries in the molecular mechanisms controlling circadian rhythms.

She explained the process for developing the plan and subsequent approval. Publication is expected in November or December of 2021. The plan focuses on trans-NIH activities over the next 5 years, serving as guidance rather than limiting activities. Dr. Brown then reviewed the five strategic goals of the plan, with the underlying goal being fostering the development of a strong and diverse workforce for sleep and circadian research. Each goal aligns with a cross-cutting theme of the NIH-wide strategic plan.

Dr. Brown closed by outlining the steps planned to ensure that the revised NIH Sleep Research Plan reaches the community, has its yearly progress tracked, and achieves sustainability.

V. NHLBI CONCEPT CLEARANCE

NHLBI staff presented 18 concepts for clearance. Members of the NHLBAC were asked to rate the concepts on six criteria using Decision Lens.

Titles: New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI-CS): Clinical/Community Field Centers (UG3/UH3); New Epidemiological Cohort Study among Asian Americans, Native Hawaiians, and Pacific Islanders (AsA-NHPI-CS): Coordinating Center (U24)

Description: These concepts support clinical, community, and coordinating centers for a new epidemiological cohort study among Asian Americans, Native Hawaiians, and Pacific Islanders. This population is one of the fastest growing in the United States and is extremely understudied. This research will meet the urgent need for robust prospective studies with the ability for data disaggregation among subgroups of these ethnic groups.

Title: Coronary Artery Risk Development in Young Adults (CARDIA) Study Renewal (N01)

Description: This concept proposes renewal of contract support for the infrastructure component of the CARDIA study. CARDIA has evolved into an adult life course study of cardiovascular lung and brain aging with outstanding cohort retention and scientific productivity. Renewal of contract support would allow NHLBI to build on its 40-year investment in this unique and productive study.

Title: NHLBI Secondary Participation in RFA-DK-21-503 “Limited Competition of Epidemiology of Diabetes Interventions and Complications (EDIC) Study Clinical Research Center” (Collaborative U01)

Description: This concept requests secondary participation in a long-term clinical trial, led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), of intensive glycemic control in patients with Type 1 diabetes. The cohorts are aging into the early geriatric age group, a population whose continued survival has been made possible by the current era of intensive therapy. This rich phenotype resource would allow evaluation of cardiovascular and sleep health in a unique population.

Title: Renewal of Co-funding (FY2023-FY2026) for the Adolescent Brain Cognitive Development (ABCD) Study (U24)

Description: This concept would renew NHLBI participation via co-funding of the trans-NIH ABCD study, which emphasizes understanding of brain cognitive, social, and emotional development during a key transformational period of human life. It will support the collection of heart, lung, blood, and sleep data as part of a deep dive into human development.

Title: Renewal of Secondary Support for NIDDK’s Chronic Kidney Disease in Children (CKiD) Cohort Study (U01)

Description: This concept requests renewal of secondary support for NIDDK’s CKiD study. CKiD is a prospective, multicenter, longitudinal study that follows children with impaired kidney function to assess the impact of chronic kidney disease progression on quality of life, cardiovascular disease, and other health outcomes. Many of these children are now entering early adulthood, a critical period of change in cardiovascular health.

Title: 2022 Renewal of Mortality Disparities in American Communities Study NHLBI Inter-Agency Agreement with the Census Bureau, Funding Cycle: August 2022 through July 2026 (Y01)

Description: This concept would renew the NHLBI interagency agreement with the U.S. Census Bureau to support the study of mortality disparities in American communities. This study enables research on individual- and societal-level characteristics for a broad range of diseases and mortality outcomes. Census records have been linked with death and healthcare utilization records to allow studies of longitudinal health disparity trends. NHLBI stimulation can make this study an even more valuable population science resource.

Title: Secondary participation in the NIBIB Point-of-Care Technology Research Network (U54)

Description: This concept is a renewal of funding for an NHLBI research center in the trans-NIH Point-of Care Technology Research Network. This center would fill a critical gap in clinical validation and adoption studies for technologies with an intended use in low resource settings. NHLBI’s continued participation would facilitate late-stage translational research and accelerate the diffusion of technologies to the communities that need them most.

Title: Secondary sign-on: Senator Paul D. Wellstone Muscular Dystrophy Specialized Research Centers (MDSRC) (P50 Clinical Trial Optional)

Description: This concept would fund secondary support for the trans-NIH Center program that was established as part of NIH’s enhancement of muscular dystrophy research. These centers promote collaborative basic translational and clinical research and provide important resources that can be used by the national muscular dystrophy research community. New to the program are adding young investigators to the leadership teams and having part of the study include understudied areas that are relevant to NHLBI’s mission.

Title: Secondary Analysis of Existing Datasets in Heart, Lung, and Blood Diseases and Sleep Disorders (R21)

Description: The goals proposed in this concept are to stimulate use of existing datasets and support early-stage investigators’ career development. Future availability of BioData Catalyst data and COVID-19 open access data will increase research opportunities and demand for secondary analysis funding. This program has been cost effective and extremely productive across heart, lung, blood, and sleep domains, and NHLBI believes that that will continue to be the case.

Titles: Optimizing Investigator-initiated Multi-site Clinical Trial FOAs—Clinical Coordinating Center (UG3, UH3); Optimizing Investigator-initiated Single-site Clinical Trial FOA (R33, R61); Optimizing Investigator-initiated Multi-site Clinical Trial FOAs – Data Coordinating Center (U24)

Description: This group of concepts would allow renewal of the program announcements that allow investigators to apply to NHLBI for funds to support multisite or single-site clinical trials. These program announcements pertain to investigator-initiated applications to conduct efficacy, comparative effectiveness, pragmatic, or implementation research clinical trials. To foster trial completion, NHLBI reviews applications for operational feasibility as well as scientific merit, and multisite trials are funded through phased and milestone-based cooperative agreements. NHLBI is considering modifying funding opportunity announcements to encourage applications that address the need for increased diversity in both participants and investigators, as well as those that foster community engagement.

Title: CIBMTR Renewal: Data Resource for Analyzing Blood and Marrow Transplants (Limited Competition U24)

Description: This concept supports renewal of secondary participation in a National Cancer Institute-led resource program, the Center for International Blood and Marrow Transplant Research (CIBMTR), which is an unparalleled resource for research in blood stem cell transplantation and cell therapies. The CIBMTR database is high quality, contemporary, longitudinal, and designed for research. The purpose of NHLBI co-funding is to facilitate observational research for mission-relevant diseases.

Title: Maximizing the Scientific Value of the NHLBI Biologic Biospecimen Repository: Scientific Opportunities for Exploratory Research (R21)

Description: The aims of this concept are to maximize the scientific value of NHLBI’s biospecimens repository and promote the use of this resource by early-stage investigators. The NHLBI established the biorepository as an open resource comprising biospecimens and data from completed clinical trials in heart, lung, and blood diseases; transfusion medicine; and cellular therapies. In the past, numerous requests were not fulfilled because the investigators were not able to procure their own funding. This concept will leverage two NHLBI-wide resources, one for BioLink, and the other for the biorepository.

Titles: Support for Research Excellence (SuRE) Award (R16 - Clinical Trial Not Allowed); Support for Research Excellence - First Independent Research Support & Transition (SuRE-First) (R16 - Clinical Trial Not Allowed)

Description: These concepts are requests for secondary participation in the NIH-wide SuRE program. SuRE-eligible institutions enroll significant numbers of students from backgrounds that are nationally underrepresented in biomedical research, as well as institutions that award undergraduate or graduate degrees in biomedical sciences and receive limited NIH research grant support. These funding announcements, which replace the Support of Competitive Research (SCORE) awards, represent opportunities to help diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in biomedicine and are a very important part of NHLBI’s program to advance diversity as part of overall inclusive excellence. The first concept provides research grant support for faculty investigators who have prior research experience in leading externally funded independent research but are not currently funded by any NIH research project grant, except for a previous SCORE award. The purpose of the second concept is to support research grants for faculty investigators who have not had any prior independent external research grants, including no previous SCORE awards.

Title: Secondary Sign-On: Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)

Description: This concept aims to support NHLBI’s participation in the National Institute of Minority Health and Health Disparities’ small-business grant program. This program funds the development of new home diagnostic and monitoring devices which target the needs of underserved populations. Although advances in digital health, telemedicine, and point-of-care technologies improve the ability of patients to manage their health, several issues prevent these technologies from being widely used among underserved populations. This funding announcement focuses on developing technologies that will assist in overcoming social determinants of health and barriers that include physical knowledge, infrastructure, and economic and cultural barriers.

CLOSING REMARKS

Dr. Moen adjourned the meeting at 2:32 p.m.