National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

A -- EVALUATION STUDY OF CONGESTIVE HEART FAILURE AND PULMONARY ARTERY CATHETERIZATION EFFECTIVENESS (ESCAPE) SOL RFP NHLBI-HV-98-24 DUE 120198 POC Sharon M. Kraft, Contracting Officer; (301) 435-0340, fax (301) 480-3338 WEB: Click here to download a copy of the RFP., http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. E-MAIL: Click here to contact the contracting officer via, sk40@nih.gov. The National Heart, Lung, and Blood Institute has a requirement for a Clinical Coordinating Network Center (CCNC) contractor to conduct a randomized trial comparing the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy to a treatment strategy without the use of PAC on morbidity and mortality in patients with New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF). The following hypothesis is to be tested: "For patients hospitalized with persistent symptoms of CHF at rest or with minimal exertion, therapy tailored using invasive hemodynamic monitoring results in a better clinical outcome than therapy without invasive monitoring." Both approaches are currently being used by clinicians managing patients with severe CHF. The primary endpoint is a combined endpoint of rehospitalization and death at six months. It is estimated a total sample size of 500 patients will be needed for the two treatment strategies to ensure at least 80% power for a two group comparison with alpha=0.05 to detect a benefit difference of 30% or greater in the primary endpoint. The Clinical Coordinating Network Center (CCNC) for the ESCAPE trial will participate in and have the following responsibilities: (1) provide the study protocol, Manual of Operations, and data gathering forms; (2) recruit a minimum of 500 patients, with evidence to support exposure to adequate patient population and medical and lay community support; (3) have IRB human subjects clearances and assurances from all participants within the CCNC; (4) carry out uniform data entry and collection from all participating units within the network; (5) carry out protocol uniformity at all recruitment sites; (6) implement a random assignment system for patient entry into the ESCAPE trial at each clinical unit in place and available twenty four hours a day; (7) monitor patient recruitment reports during the recruitment period; (8) monitor and maintain data files with appropriate confidentiality and quality control measures; (9) perform and provide for uniform (central) analysis of the following measurements: echocardiogram during index hospitalization and six month follow up; circulating levels of neuro/natriuretic peptides, such as pro-ANF, at baseline, discharge, and six month follow up; (10) regularly review quality of all data transmitted by the clinical sites; (11) provide appropriate methods of analysis and presentation of data collected during the course of the study; (12) establish a Morbidity and Mortality Classification Committee (MMCC) to review events throughout the study duration, and fund all related expenses; (13) arrange and manage all Data Safety Monitoring Board activities; and (14) perform statistical analyses and report drafting activities necessary to generate technical reports and scientific publications of the results of the study. This fixed price contract will be awarded for three years and six months. This is not a Request for Proposals (RFP). RFP No. NHLBI-HV-98-24 will be released on or about August 4, 1998 on the NHLBI contracts web page at http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. There are no paper copies. Interested organizations should review and download the streamlined RFP designated as RFP # NHLBI-HV-98-24 which will appear under the list of RFPs for the National Heart, Lung, and Blood Institute. Further instructions and forms for proposal submission are located at the menu selection entitled "Streamlined RFP References" which is located at the web page for the NIH Request For Proposals Directory, URL: http://silk.nih.gov/gov/silk/contract/rfps/ mainpage.htm. This proposed program is not set aside for small business vendors; the SICC is 8731. Posted 07/20/98 (W-SN225599). (0201)

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