Pragmatic clinical trial on efficacy of managing reduced iron stores on risk of clinically important events in older adults with heart failure and anemia (U01 Clinical Trial Required) | PA 19 230

Opportunity Information: Apply for PA 19 230

The National Institutes of Health (NIH) announced a discretionary funding opportunity (Funding Opportunity Number PA-19-230) for a U01 cooperative agreement to support a pragmatic clinical trial focused on older adults who have heart failure and anemia. The core purpose of the project is to determine whether actively managing reduced iron stores (that is, identifying and treating iron deficiency or low iron reserves) can reduce the risk of clinically important events in this population. In practical terms, the trial is meant to generate real-world, decision-ready evidence about whether an iron-management strategy improves outcomes that matter in routine care for older patients, rather than only improving lab values.

This opportunity specifically calls for a pragmatic clinical trial, meaning the study design is expected to reflect typical clinical settings and standard workflows as much as possible. The emphasis is on establishing efficacy of an iron management approach on meaningful outcomes in older adults with heart failure and anemia, such as events that would be considered clinically significant in day-to-day practice (for example, outcomes related to worsening heart failure, hospital use, serious complications, or other major health events). Because the FOA is labeled “Clinical Trial Required,” applications are expected to include an actual trial plan rather than observational or preclinical work.

The funding mechanism is a cooperative agreement (U01), which generally indicates substantial NIH program involvement during the life of the award compared with a standard research project grant. Applicants should expect active collaboration with NIH staff on elements such as study oversight, milestones, and trial conduct expectations. The activity category is Health, and the associated CFDA number listed is 93.866.

A wide range of U.S.-based organizations are eligible to apply. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (in both cases, other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as allowed under NIH rules. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), regional organizations, U.S. territories or possessions, and eligible federal agencies.

Foreign participation is explicitly restricted. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. In effect, the work and organizational structure for the proposed trial must remain fully domestic under NIH policy.

The opportunity was created on March 28, 2019, and the original closing date listed is July 5, 2022. The excerpted record does not provide an award ceiling or the expected number of awards, so applicants would typically need to consult the full FOA text and related NIH guidance for budget expectations, project period norms, review criteria, and required application components (such as data sharing plans, trial registration expectations, and human subjects protections) that commonly apply to NIH-funded clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pragmatic clinical trial on efficacy of managing reduced iron stores on risk of clinically important events in older adults with heart failure and anemia (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
• This funding opportunity was created on 2019-03-28.
• Applicants must submit their applications by 2022-07-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PA 19 230

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: