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PHASE VII

The NHLBI has issued contract awards to support the Strong Heart Study (SHS) infrastructure and continued surveillance during a Phase VII (beginning February, 2019 for a seven-year duration). Support for a basic follow-up examination of approximately 3,500 participants during the contract cycle will be included. The SHS Phase VII exam will serve as a platform for in-depth ancillary studies that are funded outside of the SHS contracts. These ancillary studies will be operationally integrated into the main study, and can propose additional exam components. See NOT-HL-19-687.

 Ancillary Studies to the SHS Phase VII Participant Re-exam

The SHS Phase VII exam of all consenting participants will occur February, 2022 to February, 2024. The exam is intended in part to serve as a platform for additional, 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 the SHS’s objectives.

Please read below for more information on Ancillary Study opportunities. Interested investigators are also encouraged to see NOT-HL-19-687 and references therein for suggested submission dates to allow adequate time to cooperate with the SHS in the planning of the SHS Phase VII exam.

SHS is Soliciting Ancillary Studies

Ancillary study proposals may be submitted using the SHS online submission portal ( ). However, those unfamiliar with conducting research in partnership with American Indian communities are encouraged to contact the SHS investigators to begin planning their proposals. In addition, the SHS considers pre-review of proposal ideas that can be presented and discussed at the monthly SHS Steering Committee videoconference calls (first Tuesday of the month at 4:00pm ET) or at the in-person Steering Committee meetings tentatively scheduled for mid-November 2019 in Bethesda, Maryland and early March in Phoenix, Arizona. Please see Guidelines for preparing submissions for pre-review.: Guidelines for Ancillary Studies submitted for pre-review by the SHS Steering Committee (PDF). Submissions are generally due 2 weeks before the intended scheduled meeting presentation. Investigators may then be encouraged to submit a more complete ancillary study proposal using the online submission portal ( ).

SHS Phase VII exam Components

For planning purposes, the components of the basic core examination will include the following: recruitment, informed consent, blood pressure and anthropometry measurements, phlebotomy and spot urine for key lab analytes (serum lipid profile, plasma glucose, whole blood HbA1c; and urinary creatinine and albumin) and sample storage for future research use, and questionnaires to update personal and medical history and current medications use.

SHS Phase VII Exam Timing:

Planning of exam components, obtaining IRB and Tribal Approvals: February 15, 2021 to February 14, 2022

Phase VII exam: February 15, 2022 to February 14, 2024