Heart Failure Clinical Trials Network

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In this proposal, the Division of Cardiology at Emory University seeks to become a Regional Clinical Center (RCC) within NHLBI's Heart Failure (HF) Clinical Research Network, a network of centers with active HF programs interested in generating and promoting evidence-based HF practice. Herein, we describe our HF and related programs, collaborators, and related clinical and research programs and institutions, our research and other accomplishments, and our faculty and key personnel; we also provide evidence of our institutional and individual expertise in clinical trials in HF, as well as documentation of access to relevant patient populations including women and minorities, extraordinary volume of HF patients, and multidi- sciplinary collaboration in the proposed Emory RCC. We believe that the Emory University infrastructure and investigators are well-equipped to achieve the primary and secondary goals of the Network. If chosen as a RCC, the Emory team will work diligently to achieve the various aims for the Network. We also seek to develop and implement a Clinical Research Skills Development Core to assist new investigators in developing their research skills, thus taking advantage of the rich environment presented by the Network and build upon the core of well trained clinical researchers within cardiovascular medicine focused on HF. As an indication of our ability to conceive, design, and conduct clinical trials, we also propose a randomized, placebo-controlled clinical trial (Nitric Oxide induced Vasodilation Evaluation in acute HF - NOVEL-HF) to evaluate the efficacy of the oral combination of hydralazine plus isosorbide dinitrate (H-ISDN) in patients with HF due to systolic dysfunction admitted with acute decompensated HF (AHDF). This therapy is associated with hemodynamic benefits that could improve outcomes in ADHF based on observational data. Emory University has a longstanding commitment to diversity and the population mix in the city of Atlanta offers a rich environment to study the similarities and differences in treatment among diverse patient groups. We therefore propose a clinical trial to assess a key clinical question facing HF medicine today, i.e. the role of H- ISDN in ADHF, its benefits and mechanisms of action, and outcomes in black versus non-black HF patients. RELEVANCE (See instructions): Heart failure affects over 6 million Americans with a high mortality and hospitalization rate, and is currently a national healthcare priority. Emory, with a record of excellence in clinical and research programs for heart failure, an extraordinary clinical network, and a longstanding commitment to diversity, seeks to help improve outcomes for patients with heart failure by participating in NHLBI's Heart Failure Clinical Research Network.