This $1,200,000 Project Grant award from the Food and Drug Administration (FDA) Research program (CFDA 93.103) supports a comprehensive natural history study for Congenital Central Hypoventilation Syndrome (CCHS), a rare and severe neurocristopathy. The award, granted to the Ann & Robert H. Lurie Children's Hospital of Chicago, aims to develop a flexible data hub of core measures to advance CCHS therapeutic development, intervention trials, research, and clinical care. Key activities include...
This $499,774 cooperative agreement from the Department of Health and Human Services' Food and Drug Administration will support the University of California, San Diego in qualifying composite quantitative imaging biomarkers for diagnostic enrichment in nonalcoholic steatohepatitis (NASH) clinical trials. Over the one-year period from September 1, 2022 to August 31, 2023, UC San Diego will prepare and submit a biomarker qualification plan to the FDA's Center for Drug Evaluation and Research...
This Project Grant award from the National Heart, Lung, and Blood Institute (CFDA 93.837 - Cardiovascular Diseases Research) to Yale University is for $477,959 over the period of Sep 2, 2024 to Jun 30, 2027. The project aims to design and pilot test the "Promoting Palliative Care for People with Heart Failure (P3HF)" clinical decision support (CDS) tool. The P3HF CDS will incorporate an automated 1-year mortality risk model for heart failure patients to facilitate referrals to...
This Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), funded under the Cardiovascular Diseases Research program (CFDA 93.837), will support a $198,936 research project conducted by New York University School of Medicine. The project aims to investigate the impact of restrictive drug coverage policies, such as cost-sharing and prior authorization requirements, on prescribing patterns, medication adherence, and clinical outcomes for patients with heart failure with...
This Project Grant award from the National Heart Lung and Blood Institute (CFDA 93.837 - Cardiovascular Diseases Research) provides $706,573.00 to Yale University to develop novel statistical methods for analyzing multiple and composite outcomes in cluster-randomized trials (CRTs) focused on improving patient care for heart failure. The project aims to: 1) create efficient covariate-adjusted estimators for "win" statistics (net benefit, win ratio, win odds) in CRTs with multivariate...
This Project Grant award from the National Heart, Lung, and Blood Institute (CFDA 93.837 - Cardiovascular Diseases Research) provides $500,000 in funding to Aventusoft LLC, a small business located in Boca Raton, FL. The goal of this late-stage development project is to advance Aventusoft's non-invasive "HATS-OFF" heart failure monitoring technology towards commercialization. Specifically, the award will enable Aventusoft to: 1) Manufacture the HATS-OFF device with added ECG...
This National Heart, Lung, and Blood Institute (NHLBI) Project Grant award under CFDA 93.837 Cardiovascular Diseases Research provides $1,044,896 to 3-C Institute For Social Development Inc. (doing business as 3C Institute), a woman-owned small business, to develop a comprehensive digital platform called FBT 2.0. The FBT 2.0 platform will deliver an integrated suite of intervention components for family-based behavioral treatment (FBT) of childhood obesity, including personalized self-paced...
This Project Grant award from the National Institutes of Health (NIH) Trans-NIH Research Support program (CFDA 93.310) will provide $315,999 to the Research Institute at Nationwide Children's Hospital to conduct research aimed at uncovering the role of incomplete penetrance genes in congenital heart disease (CHD). The key products and services to be delivered include: Sourcing a large cohort of CHD families from multiple data sources to perform a genetic association study and pedigree...
This $701,842 Project Grant, awarded by the National Heart, Lung, and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837), will support research at the University of South Florida to investigate the role of the CDK13 gene in the development of congenital heart defects. The project aims to utilize mouse models and human induced pluripotent stem cell-derived cardiomyocytes to better understand how mutations in CDK13 disrupt RNA processing and lead to cardiac...
This federal Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), provides $777,674 to The General Hospital Corporation (doing business as Massachusetts General Hospital) to build the largest echocardiography registry in the world and apply advanced causal inference methods to measure the effects of guideline-directed medical therapies on mortality in patients with heart failure and mid-range ejection...