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, th 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 #
1U10HL110312-01
Application #
8196429
Study Section
Special Emphasis Panel (ZHL1-CSR-K (O2))
Program Officer
Mascette, Alice
Project Start
2012-01-01
Project End
2018-12-31
Budget Start
2012-01-01
Budget End
2012-12-31
Support Year
1
Fiscal Year
2012
Total Cost
$506,123
Indirect Cost
$178,306
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Vader, Justin M; LaRue, Shane J; Stevens, Susanna R et al. (2016) Timing and Causes of Readmission After Acute Heart Failure Hospitalization-Insights From the Heart Failure Network Trials. J Card Fail 22:875-883
AbouEzzeddine, Omar F; Lala, Anuradha; Khazanie, Prateeti P et al. (2016) Evaluation of a provocative dyspnea severity score in acute heart failure. Am Heart J 172:34-41
Wan, Siu-Hin; Stevens, Susanna R; Borlaug, Barry A et al. (2016) Differential Response to Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Reduced or Preserved Ejection Fraction: Results From the ROSE AHF Trial (Renal Optimization Strategies Evaluation in Acute Heart Failure). Circ Heart Fail 9:
Parikh, Kishan S; Coles, Adrian; Schulte, Phillip J et al. (2016) Relation of Angina Pectoris to Outcomes, Quality of Life, and Response to Exercise Training in Patients With Chronic Heart Failure (from HF-ACTION). Am J Cardiol 118:1211-1216
Grodin, Justin L; Lala, Anuradha; Stevens, Susanna R et al. (2016) Clinical Implications of Serum Albumin Levels in Acute Heart Failure: Insights From DOSE-AHF and ROSE-AHF. J Card Fail 22:884-890
Butler, Javed; Hernandez, Adrian F; Anstrom, Kevin J et al. (2016) Rationale and Design of the ATHENA-HF Trial: Aldosterone Targeted Neurohormonal Combined With Natriuresis Therapy in Heart Failure. JACC Heart Fail 4:726-35
Grodin, Justin L; Stevens, Susanna R; de Las Fuentes, Lisa et al. (2016) Intensification of Medication Therapy for Cardiorenal Syndrome in Acute Decompensated Heart Failure. J Card Fail 22:26-32
Mentz, Robert J; Hernandez, Adrian F; Berdan, Lisa G et al. (2016) Good Clinical Practice Guidance and Pragmatic Clinical Trials: Balancing the Best of Both Worlds. Circulation 133:872-80
Luo, Nancy; Rogers, Joseph G; Dodson, Gwen C et al. (2016) Usefulness of Palliative Care to Complement the Management of Patients on Left Ventricular Assist Devices. Am J Cardiol 118:733-8
Margulies, Kenneth B; Hernandez, Adrian F; Redfield, Margaret M et al. (2016) Effects of Liraglutide on Clinical Stability Among Patients With Advanced Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA 316:500-8

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