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 #
5U10HL084904-12
Application #
9398035
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Desvigne-Nickens, Patrice
Project Start
2006-09-30
Project End
2018-10-31
Budget Start
2017-11-01
Budget End
2018-10-31
Support Year
12
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Grodin, Justin L; Gallup, Dianne; Anstrom, Kevin J et al. (2017) Implications of Alternative Hepatorenal Prognostic Scoring Systems in Acute Heart Failure (from DOSE-AHF and ROSE-AHF). Am J Cardiol 119:2003-2009
de Denus, S; Rouleau, J L; Mann, D L et al. (2017) CYP3A4 genotype is associated with sildenafil concentrations in patients with heart failure with preserved ejection fraction. Pharmacogenomics J :
Butler, Javed; Anstrom, Kevin J; Felker, G Michael et al. (2017) Efficacy and Safety of Spironolactone in Acute Heart Failure: The ATHENA-HF Randomized Clinical Trial. JAMA Cardiol 2:950-958
Reddy, Yogesh N V; Lewis, Gregory D; Shah, Sanjiv J et al. (2017) INDIE-HFpEF (Inorganic Nitrite Delivery to Improve Exercise Capacity in Heart Failure With Preserved Ejection Fraction): Rationale and Design. Circ Heart Fail 10:
Grodin, Justin L; Sun, Jie-Lena; Anstrom, Kevin J et al. (2017) Implications of Serum Chloride Homeostasis in Acute Heart Failure (from ROSE-AHF). Am J Cardiol 119:78-83
de Denus, S; Rouleau, J L; Mann, D L et al. (2017) A pharmacogenetic investigation of intravenous furosemide in decompensated heart failure: a meta-analysis of three clinical trials. Pharmacogenomics J 17:192-200
Lewis, Gregory D; Malhotra, Rajeev; Hernandez, Adrian F et al. (2017) Effect of Oral Iron Repletion on Exercise Capacity in Patients With Heart Failure With Reduced Ejection Fraction and Iron Deficiency: The IRONOUT HF Randomized Clinical Trial. JAMA 317:1958-1966
Ambrosy, Andrew P; Bhatt, Ankeet S; Gallup, Dianne et al. (2017) Trajectory of Congestion Metrics by Ejection Fraction in Patients With Acute Heart Failure (from the Heart Failure Network). Am J Cardiol 120:98-105
DeVore, Adam D; McNulty, Steven; Alenezi, Fawaz et al. (2017) Impaired left ventricular global longitudinal strain in patients with heart failure with preserved ejection fraction: insights from the RELAX trial. Eur J Heart Fail 19:893-900
Snipelisky, David; Kelly, Jacob; Levine, James A et al. (2017) Accelerometer-Measured Daily Activity in Heart Failure With Preserved Ejection Fraction: Clinical Correlates and Association With Standard Heart Failure Severity Indices. Circ Heart Fail 10:e003878

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