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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
4U10HL110312-05
Application #
8985611
Study Section
Special Emphasis Panel (ZHL1-CSR-K (O2))
Program Officer
Shah, Monica R
Project Start
2012-01-01
Project End
2018-12-31
Budget Start
2016-01-01
Budget End
2016-12-31
Support Year
5
Fiscal Year
2016
Total Cost
$500,086
Indirect Cost
$176,195
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Luo, Nancy; O'Connor, Christopher M; Cooper, Lauren B et al. (2018) Relationship between changing patient-reported outcomes and subsequent clinical events in patients with chronic heart failure: insights from HF-ACTION. Eur J Heart Fail :
Verma, Amanda K; Sun, Jie-Lena; Hernandez, Adrian et al. (2018) Rate pressure product and the components of heart rate and systolic blood pressure in hospitalized heart failure patients with preserved ejection fraction: Insights from ASCEND-HF. Clin Cardiol 41:945-952
Pastva, Amy M; Duncan, Pamela W; Reeves, Gordon R et al. (2018) Strategies for supporting intervention fidelity in the rehabilitation therapy in older acute heart failure patients (REHAB-HF) trial. Contemp Clin Trials 64:118-127
Kiernan, Michael S; Stevens, Susanna R; Tang, W H Wilson et al. (2018) Determinants of Diuretic Responsiveness and Associated Outcomes During Acute Heart Failure Hospitalization: An Analysis From the NHLBI Heart Failure Network Clinical Trials. J Card Fail 24:428-438
Greene, Stephen J; Hernandez, Adrian F; Sun, Jie-Lena et al. (2018) Relationship Between Enrolling Country Income Level and Patient Profile, Protocol Completion, and Trial End Points. Circ Cardiovasc Qual Outcomes 11:e004783
Mentz, Robert J; Greiner, Melissa A; Muntner, Paul et al. (2018) Intentional and unintentional medication non-adherence in African Americans: Insights from the Jackson Heart Study. Am Heart J 200:51-59
Borlaug, Barry A; Anstrom, Kevin J; Lewis, Gregory D et al. (2018) Effect of Inorganic Nitrite vs Placebo on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: The INDIE-HFpEF Randomized Clinical Trial. JAMA 320:1764-1773
Napier, Rebecca; McNulty, Steven E; Eton, David T et al. (2018) Comparing Measures to Assess Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail 6:552-560
Butler, Javed; Kalogeropoulos, Andreas P; Anstrom, Kevin J et al. (2018) Diastolic Dysfunction in Individuals With Human Immunodeficiency Virus Infection: Literature Review, Rationale and Design of the Characterizing Heart Function on Antiretroviral Therapy (CHART) Study. J Card Fail 24:255-265
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

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