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 NHLBI-HV-98-24 DUE 071398 POC Sharon M. Kraft, Contracting Officer, (301)435-0340 WEB: NIH Research Contracts RFP Directory, http://www4.od.nih.gov/ocm/contracts/rfps/mainpage.htm. E-MAIL: click here to contact the, sk40f@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. Small businesses which believe they have the capability to perform this project are invited to submit capability statements to demonstrate the ability to recruit a total of 500 patients meeting the above criteria; prior experience in comparable multicenter clinical trials in cardiovascular disease and the demonstrated abilities to implement a comparable study protocol in a standardized fashion, to coordinate a follow-up of study patients, and to provide the study protocol and manual of operations, adequate communication links within the network, and data gathering and analysis and quality control measures; evidence of specific competence of professional, technical and administrative staff pertinent to the operation of the CCNC, collaborating in multicenter clinical trials in cardiovascular disease, on site medical consultation, the time these professionals will devote to the project, and the organizational and administrative structure of the proposed CCNC; and the adequacy of the proposed facility(s), technical hardware, and space. This is not a Request for Proposals (RFP), and the Government is not committed to award a contract pursuant to this announcement. No RFP is currently available.Provide an original and five copies of your capability statement within fifteen (15) calendar days from the date of publication of this announcement in the Commerce Business Daily (CBD). Posted 06/25/98 (0176)

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