The National Heart, Lung, and Blood Institute (NHLBI) has proposed an initiative to establish a Heart Failure (HF) Clinical Research Network with the overall goal of accelerating research in the diagnosis, management, and treatment of heart failure, and thereby improving patient outcomes in the rapid growing population of HF patients. The HF Network will be structured to have up to eight regional clinical centers to perform multiple clinical studies and one Data Coordinating Center (DCC). The network will provide the necessary infrastructure to develop, coordinate, and conduct multiple concurrent studies and facilitate the efficient application of emerging basic science discoveries into well-designed clinical investigations. The Duke Clinical Research Institute (DCRI) proposes to serve as the Data Coordinating Center for the HF Network. In this role, the DCRI will coordinate and manage the clinical research and organizational activities of the HF Network. Using our extensive research experience and infrastructure, we will assist in developing study protocols, monitoring data collection activities, providing protocol-specific training of clinical centers, and performing state-of-the-art statistical analyses. We have assembled a team of experts in biostatistics, cardiology (including heart failure), and clinical trials to ensure that scientifically defensible and clinically meaningful conclusions can be drawn. We will promote the progress of the HF Network through a wide-variety of interfaces including web-based technologies, national cardiology and heart failure meetings, and scientific publications. To achieve the objectives of the HF Network, the DCRI will focus on the following activities: (1) study coordination and planning, (2) study design and protocol development, (3) site management, monitoring for quality assurance, and regulatory requirements, (4) data management and reporting activities, (4) statistical data analysis, and (5) publication and dissemination of results. Through its vast experience in coordinating other cardiology and heart failure trials, and through the services it will provide to the HF Network, the DCRI as the DCC will be a vital resource in the successful establishment of this important network.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL084904-05
Application #
7878643
Study Section
Special Emphasis Panel (ZHL1-CSR-H (M1))
Program Officer
Mascette, Alice
Project Start
2006-09-30
Project End
2011-12-31
Budget Start
2011-07-01
Budget End
2011-12-31
Support Year
5
Fiscal Year
2011
Total Cost
$4,390,186
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
de Denus, S; Rouleau, J L; Mann, D L et al. (2018) CYP3A4 genotype is associated with sildenafil concentrations in patients with heart failure with preserved ejection fraction. Pharmacogenomics J 18:232-237
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
AbouEzzeddine, Omar F; McKie, Paul M; Dunlay, Shannon M et al. (2017) Suppression of Tumorigenicity 2 in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc 6:
Gandhi, Parul U; Gaggin, Hanna K; Redfield, Margaret M et al. (2016) Insulin-Like Growth Factor-Binding Protein-7 as a Biomarker of Diastolic Dysfunction and Functional Capacity in Heart Failure With Preserved Ejection Fraction: Results From the RELAX Trial. JACC Heart Fail 4:860-869
AbouEzzeddine, Omar F; Haines, Phillip; Stevens, Susanna et al. (2015) Galectin-3 in heart failure with preserved ejection fraction. A RELAX trial substudy (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure). JACC Heart Fail 3:245-52
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
Shankar, Nisha; Daly, Richard; Geske, Jennifer et al. (2013) LVAD implant as a bridge to heart transplantation is associated with allosensitization as measured by single antigen bead assay. Transplantation 96:324-30
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
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
Kociol, Robb D; McNulty, Steven E; Hernandez, Adrian F et al. (2013) Markers of decongestion, dyspnea relief, and clinical outcomes among patients hospitalized with acute heart failure. Circ Heart Fail 6:240-5

Showing the most recent 10 out of 21 publications