A -- A-Aldosterone Antagonists for the Treatment of Heart Failure with Preserved Systolic Function

The National Heart, Lung, and Blood Institute is soliciting proposals from all interested organizations to perform as a Clinical Trials Coordinating Center (CTCC) for a 5,000 patient randomized controlled trial of aldosterone-antagonist treatment of heart failure patients with preserved systolic function. The CTCC will select and manage a network of clinics who can adequately recruit patients with heart failure and preserved systolic function (HF and PSF) (left ventricular ejection fraction > 0.40) in the absence of severe valve disease, and treat and follow them according to a study protocol. In addition, the CTCC will subcontract three components including: (1) an echocardiography and tonometry core laboratory that will analyze serial studies to examine the effect of treatment on ventricular and vascular compliance, and ventricular-vascular coupling; (2) a pharmacogenetics component that will collect and store blood and urine for both immediate and future studies of biomarkers of disease severity and progression as well as response to treatment; and (3) an economics and quality of life component. The period of performance is for 6.5 years beginning on or about August 1, 2004. This announcement invites all responsible sources interested in performing as the Clinical Trials Coordinating Center for this study to submit a proposal which shall be considered by the agency. This is not the Request for Proposal (RFP); the Request for Proposal (RFP # NHLBI-HC-04-19) must be downloaded from the NIH Web Site, which will be available on or about July 31, 2003, at the following internet address: http://www.nhlbi.nih.gov/nhlbi/rafs/rfas.htm. The due date for proposal submission is November 4, 2003.