This proposal represents an application by the Mayo Clinic to be a REGIONAL CLINICAL CENTER (RCC) and a site for a CLINICAL RESEARCH SKILLS DEVELOPMENT CORE (SDC) in the Heart Failure Clinical Research Network (HFCRN). Mayo was a RCC and SDC site in the first funding period of the HFCRN. The Mayo RCC investigators designed and as serve as the principal investigator (PI) on two HFCRN trials (RELAX and ROSE) and three ancillary studies. We lead enrollment across the nine HFCRN sites. Our proposed protocol is POSE (Post-hospitalization Optimization Strategies Evaluation); a randomized, double- blind, placebo-controlled trial of subcutaneous (SQ) administration of BNP added to standard therapy at hospital dismissal and continued for 30 days in patients admitted for acute heart failure syndrome (AHFS). Hypothesis: As compared to placebo, therapy with SQ BNP will be associated with greater clinical stability at 60 days post discharge as assessed by a composite HF stability score. The long-term goal of POSE is to provide the rationale for a future adequately powered phase III study to test the impact of this strategy on HF readmissions. POSE is a small proof-of-concept study which tests a innovative therapeutic strategy at a novel AHFS therapeutic window extending the time course of therapeutic interventions in AHFS into the vulnerable post-discharge period to promote further clinical stabilization. POSE targets the appropriate AHFS subgroup based on the pathophysiology of AHFS and the biological actions of the proposed therapeutic and uses a novel, highly quantitative composite endpoint reflecting clinical stability. Finally, we document the successes of the MAYO HFCRN CLINICAL RESEARCH SKILLS DEVELOPMENT CORE (SDC) in the first cycle of funding and outline our continued strategy to train academic HF physician scientists in our Mayo SDC application.

Public Health Relevance

This proposal represents an application by the existing MAYO REGIONAL CLINICAL CENTER and MAYO CLINICAL RESEARCH SKILLS DEVELOPMENT CORE to participate in the Heart Failure Clinical Research Network. Mayo's participation will advance the goal of the Network which is to improve the treatment of HF by testing, through randomized clinical trials, interventions aiding in the management of HF and its morbidity.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HL110262-06
Application #
9197911
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Lathrop, David A
Project Start
2012-01-01
Project End
2018-12-31
Budget Start
2017-01-01
Budget End
2017-12-31
Support Year
6
Fiscal Year
2017
Total Cost
Indirect Cost
Name
Mayo Clinic, Rochester
Department
Type
DUNS #
006471700
City
Rochester
State
MN
Country
United States
Zip Code
55905
Saiki, Hirofumi; Petersen, Ivy A; Scott, Christopher G et al. (2017) Risk of Heart Failure With Preserved Ejection Fraction in Older Women After Contemporary Radiotherapy for Breast Cancer. Circulation 135:1388-1396
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
Win, Sithu; Hussain, Imad; Hebl, Virginia B et al. (2017) Inpatient Mortality Risk Scores and Postdischarge Events in Hospitalized Heart Failure Patients: A Community-Based Study. Circ Heart Fail 10:
Egbe, Alexander C; Connolly, Heidi M; Miranda, William R et al. (2017) Hemodynamics of Fontan Failure: The Role of Pulmonary Vascular Disease. Circ Heart Fail 10:
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
Borlaug, Barry A; Carter, Rickey E; Melenovsky, Vojtech et al. (2017) Percutaneous Pericardial Resection: A Novel Potential Treatment for Heart Failure With Preserved Ejection Fraction. Circ Heart Fail 10:e003612
Zakeri, Rosita; Redfield, Margaret M (2017) Letter by Zakeri and Redfield Regarding Article, ""Influence of Left Atrial Function on Exercise Capacity and Left Ventricular Function in Patients With Heart Failure and Preserved Ejection Fraction"". Circ Cardiovasc Imaging 10:
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
Van Iterson, Erik H; Johnson, Bruce D; Borlaug, Barry A et al. (2017) Physiological dead space and arterial carbon dioxide contributions to exercise ventilatory inefficiency in patients with reduced or preserved ejection fraction heart failure. Eur J Heart Fail 19:1675-1685

Showing the most recent 10 out of 58 publications