The National Heart, Lung, and Blood Institute has solicited applications to continue the Heart Failure (HF) Clinical Research Netv^/ork (Network) to accelerate research in the diagnosis and management of HF and to improve patient outcomes through optimal application of existing therapies and evaluation of novel therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the combined Data Coordinating Center/Clinical Coordinating Center (CC) to provide the essential thought leadership, infrastructure, clinical and research experience, and innovative ideas necessary to support the operations and efficiency of the Network. As CC for the Network, the DCRI will support the following Specific Aims: 1) Coordinate the overall activities of the Network, Network Committees, and Core Labs, and work with the NHLBI and Steering Committee to establish reliable and efficient communication structures, 2) Provide thought leadership and operational support for trial design and protocol development, including the identification of relevant clinical endpoints, appropriate study sample sizes, randomization strategies, and the development of economic and quality-of- life endpoints, 3) Develop the Network Manual of Procedures, provide training and certification for study personnel at all clinical centers, perform site monitoring and develop performance trackers, and coordinate subcontracting including all financial and legal arrangements, 4) Establish a financial reimbursement model that will facilitate enrollment in Network studies;manage and distribute protocol funds to the clinical centers, core labs, and other vendors, 5) Develop and manage an Electronic Data Capture system, including training, quality control, data storage, and reporting, 6) Develop rigorous statistical analysis plans for each study, identifying the appropriate analytical methodology, timing of interim analyses, and a priori subgroups of interest, 7) Provide editorial, technical, and administrative support for all study publications and work with the Steering Committee to effectively communicate the findings of the HFN studies.

Public Health Relevance

The DCRI will support further innovations in heart failure clinical trials that will allow the Network to complete a number of landmark trials over the next 7 years. These trials will change professional guidelines, will provide the Phase II data necessary for appropriate large outcomes trials, and will ultimately improve clinical care of patients suffering with heart failure.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL084904-08
Application #
8601124
Study Section
Special Emphasis Panel (ZHL1-CSR-K (O2))
Program Officer
Shah, Monica R
Project Start
2006-09-30
Project End
2018-10-31
Budget Start
2013-11-01
Budget End
2014-10-31
Support Year
8
Fiscal Year
2014
Total Cost
$4,678,117
Indirect Cost
$730,562
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Mohammed, Selma F; Borlaug, Barry A; McNulty, Steven et al. (2014) Resting ventricular-vascular function and exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail 7:580-9
Zakeri, Rosita; Borlaug, Barry A; McNulty, Steven E et al. (2014) Impact of atrial fibrillation on exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study. Circ Heart Fail 7:123-30
Margulies, Kenneth B; Anstrom, Kevin J; Hernandez, Adrian F et al. (2014) GLP-1 agonist therapy for advanced heart failure with reduced ejection fraction: design and rationale for the functional impact of GLP-1 for heart failure treatment study. Circ Heart Fail 7:673-9
Lindman, Brian R; Dávila-Román, Victor G; Mann, Douglas L et al. (2014) Cardiovascular phenotype in HFpEF patients with or without diabetes: a RELAX trial ancillary study. J Am Coll Cardiol 64:541-9
Topilsky, Yan; Gandhi, Manish J; Hasin, Tal et al. (2013) Donor-specific antibodies to class II antigens are associated with accelerated cardiac allograft vasculopathy: a three-dimensional volumetric intravascular ultrasound study. Transplantation 95:389-96
Givertz, Michael M; Mann, Douglas L; Lee, Kerry L et al. (2013) Xanthine oxidase inhibition for hyperuricemic heart failure patients: design and rationale of the EXACT-HF study. Circ Heart Fail 6:862-8
Pereira, Naveen L; Lin, Dong; Pelleymounter, Linda et al. (2013) Natriuretic peptide receptor-3 gene (NPR3): nonsynonymous polymorphism results in significant reduction in protein expression because of accelerated degradation. Circ Cardiovasc Genet 6:201-10
Chen, Horng H; AbouEzzeddine, Omar F; Anstrom, Kevin J et al. (2013) Targeting the kidney in acute heart failure: can old drugs provide new benefit? Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE AHF) trial. Circ Heart Fail 6:1087-94
Redfield, Margaret M; Chen, Horng H; Borlaug, Barry A et al. (2013) Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: a randomized clinical trial. JAMA 309:1268-77
Chen, Horng H; Anstrom, Kevin J; Givertz, Michael M et al. (2013) Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial. JAMA 310:2533-43