The overriding objective of this proposal for the Duke University Medical Center Regional Clinical Center (Duke RCC) for the Heart Failure Clinical Research Network (HF Network) is to improve the care of patients with heart failure through high-impact patient-oriented clinical research. This objective will be achieved through active collaboration with all components of the HF Network, including other RCCs, the Data Coordinating Center (DCC), associated core labs, and the NHLBI. The overall goal of the HF network is to improve outcomes through optimal application of existing therapies, evaluation of novel therapies, and to facilitate application of emerging basic science discoveries into clinical investigations. We believe the Duke RCC is highly capable of contributing to the successful achievement of these objectives based on a demonstrated record of developing original, innovative, high impact clinical research protocols addressing clinically important research questions in heart failure, and propose a novel protocol targeting acute heart failure patients, the CAPTAIN study, in this application. The Duke RCC has proven ability to recruit scientifically appropriate and ethnically and racially diverse populations of patients into HF Network clinical protocols and provide data that is accurate, complete, timely, and regulatory compliant. As detailed in this proposal, the Duke RCC has a dedicated and experienced team of investigators, combining a broad array of clinical, research, and operational skills that collectively will make a major contribution to the overall success of the HF Network. The Duke RCC we will participate in the development of research protocols, statistical methods, and plans for data collection and protocol implementation. We will provide input where appropriate into study design from both a scientific and a feasibility standpoint. We will implement each network-wide protocol approved by the protocol review committee (PRC) and the NHLBI;comply with study policies and quality assurance measures approved by the Steering Committee, and agree to oversight of the study by a Data and Safety Monitoring Board (DSMB). Finally, the Duke RCC will develop a Clinical Research Skills Development Core to train future generations of heart failure researchers.

Public Health Relevance

This proposal for the Duke Regional Clinical Center of the NHLBI Heart Failure Clinical Research Network will develop and implement high impact, scientifically rigorous randomized clinical trials designed to improve the health of persons with heart failure. The results of the proposed research will have immediate clinical implications for millions of patients with heart failure.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Study Section
Special Emphasis Panel (ZHL1-CSR-K (O2))
Program Officer
Shah, Monica R
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Duke University
Internal Medicine/Medicine
Schools of Medicine
United States
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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
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
Reeves, Gordon R; Whellan, David J; Duncan, Pamela et al. (2017) Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial: Design and rationale. Am Heart J 185:130-139
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Ambrosy, Andrew P; Cerbin, Lukasz P; Armstrong, Paul W et al. (2017) Body Weight Change During and After Hospitalization for Acute Heart Failure: Patient Characteristics, Markers of Congestion, and Outcomes: Findings From the ASCEND-HF Trial. JACC Heart Fail 5:1-13
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
Luo, Nancy; Merrill, Peter; Parikh, Kishan S et al. (2017) Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation. J Am Coll Cardiol 69:1683-1691
Bhatt, Ankeet S; DeVore, Adam D; Hernandez, Adrian F et al. (2017) Can Vaccinations Improve Heart Failure Outcomes?: Contemporary Data and Future Directions. JACC Heart Fail 5:194-203
Luo, Nancy; Teng, Tiew-Hwa Katherine; Tay, Wan Ting et al. (2017) Multinational and multiethnic variations in health-related quality of life in patients with chronic heart failure. Am Heart J 191:75-81

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