U54HL160273

HeartShare Decode-HF: Data Translation Center to Combine Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets - Project Summary

The overarching aim of the Northwestern HeartShare Decode-HF: Data Translation Center to Combine Omics, Deep Phenotyping, and Electronic Health Records for Heart Failure Subtypes and Treatment Targets is to provide overall management and oversight for HeartShare. This includes coordination and communication across all subsections and cores of the program, as well as with the 4 HeartShare Clinical Centers (CCs).

The Data Translation Center (DTC) will need to ensure timely completion of the retrospective and prospective components of HeartShare. In our application, we demonstrate the ability and prior experience of our multi-PI team and core leaders in the conduct and leadership of large-scale, multi-center studies. This is particularly in the realms of heart failure with preserved ejection fraction (HFPEF), electronic health record (EHR)-based investigation, deep phenotyping, machine learning, and biorepositories.

For both the retrospective and prospective HeartShare components, the Northwestern DTC will leverage its considerable experience in cohorts and trials that have data on adjudicated HF patients. Additionally, it will leverage its leadership and track record as the top enroller in HFPEF trials/studies to ensure optimal recruitment by the HeartShare CCs. We will also leverage our expertise in HFPEF, data coordination/management, biodata catalyst, EHR-based research, biostatistics, machine learning, multi-omics, human-computer interaction, and mobile health data monitoring. This is to successfully execute the HeartShare program and meet the HeartShare DTC goals of providing a rich resource to the research community. This will advance the science of next-generation phenomics to identify HFPEF subtypes and therapeutic targets.

Our HeartShare DTC will carry out each of its 4 primary responsibilities. Firstly, the Administrative and Outreach Core will oversee HeartShare program operations, research skills development, and capitulation to CCS for deep phenotyping costs. It will also support a call center to follow patient outcomes and promote rapid and broad data-sharing of clinical and molecular data.

Secondly, the Data Portal Core will serve as the primary access point (via a web-based interface) and coordinating center for all HeartShare data. It will also develop an interactive patient-facing web-based interface for remote consent, completion of forms, and collection of mobile health data using biodata catalyst tools.

Thirdly, the Data Management Core will oversee data quality, integration, and harmonization of various data types. It will perform advanced analytics, coordinate biospecimen and imaging biorepositories, and integrate with TOPMed for omics analyses.

Lastly, the Cohort Core will aggregate data on HF patients from completed epidemiology cohorts and HF trials. It will combine data with further bioprofiling of existing samples to allow discovery/validation of novel targets.

Northwestern University

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

Chicago, Illinois 606112981 United States

Single Zip Code

HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed) (RFA-HL-21-016)

Amendment Since initial award the total obligations have increased 409% from $3,338,507 to $16,979,349.