NIH, National Heart, Lung, and Blood Institute, COB, HLVD Contracts Section, 6701 Rockledge Drive MSC 7902, Bethesda, MD

A -- LUNG VOLUME REDUCTION SURGERY FOR EMPHYSEMA: A MULTI-CENTER ASSESSMENT AND PROSPECTIVE PATIENT REGISTRY SOL NHLBI-HR-97-02 POC Joanne C. Deshler Contracting Officer (301) 435-0340. The National Heart, Lung and Blood Institute of the National Institutes of Health and the Health Care Financing Administration will jointly sponsor and support a seven year multi-center randomized, clinical trial in association with a prospective registry to examine the role of Lung Volume Reduction Surgery (LVRS) in the treatment of end-stage emphysema, evaluate the long term outcome of LVRS on function, morbidity and mortality and define appropriate patient selection criteria for the procedure. The program will consist of approximately 10 to 15 clinical centers and a coordinating center. This announcement is for clinical centers only. A separate RFP for the clinical coordinating center will be released under RFP: NHLBI-HR-97-01. Clinical centers must document a strongly integrated team with expertise in the following areas: thoracic surgery, the surgery being offered, the pre-, peri- and post-operative care of end-stage emphysema patients undergoing thoracic surgery, pulmonary medicine and the care of end-stage emphysema patients, the rehabilitation and education of end-stage emphysema patients, the conducting of clinical trials, pulmonary physiology, cardiology, radiology and evaluation of dyspnea and quality of life. In addition, the centers must document strong collaborative ties with other consultative services. The study will be conducted in three phases. Phase I (9 Months) will be for development of a protocol and manual of operations and recruitment and training of personnel. Phase II (63 Months) will be for recruitment of patients, treatment and follow-up. Phase III (12 Months) will be for analysis of data and writing of manuscripts describing results of the study. A registry will be established to serve as a repository of severe end stage emphysematous patients, who have been referred for evaluation for LVRS, transplant or pulmonary rehabilitation to any of the participating clinical centers. Baseline clinical data will be obtained on these patients. Patients in the registry meeting selection criteria will be invited for inclusion in the randomized study. Patients, who are not randomized, but agree to be in the registry will be followed twice yearly. The registry will provide 1) information on patients referred for end-stage emphysema, 2) data on the outcome of these patients, 3) provide a source of patients for randomization, and 4) allow comparison of patients who are randomized to the larger pool of patients with end stage emphysema. Patients meeting eligibility requirements will be randomized to receive either maximal medical therapy or maximal medical therapy with LVRS. LVRS will be performed by median sternotomy or by bilateral video-assisted thorascopic surgery (VATS) with excision of 20-30% of each lung. Centers will apply to randomize to either a) medical therapy versus medical therapy with LVRS by median sternotomy, b) medical therapy versus medical therapy with LVRS by bilateral VATS or c) medical therapy versus medical therapy with LVRS by median sternotomy versus medical therapy with LVRS by bilateral VATS. Maximum medical therapy will include pulmonary rehabilitation and education. End-points will include exercise ability, pulmonary function, quality of life, morbidity and mortality. The study population will consist of 200 patients recruited into each arm of the three arm trial comparing surgery A versus surgery B versus medical therapy. An additional 495 patients will be recruited into each of two arms among clinical centers performing only one kind of surgery and medical treatment. This will require a total of 2580 participants in the three armed and two arm trials combined. The Health Care Financing Administration will pay all allowable clinical costs for its beneficiaries. This is not a request for proposals. It is anticipated that RFP NHLBI-HR-97-02 will be available on or about June 3, 1996, with proposals due on or about August 5, 1996. It is to be noted that award of a contract for this study shall be made only to offerors who are located in the United States of America. The RFP will is available on the NIH RFP Gopher. Access via the NIH Home Page (World Wide Web) at http://www.nih.gov. Once you are at the NIH Home Page select ''Grants & Contracts'' then select ''R&D Requests for Proposals (RFP)''. Offerors that have access to the NIH Gopher Server but not the Internet can access the RFP by pointing your gopher client to GOPHER.NIH.GOVPORT70. Select ''Grant and Research Information'', then select ''R&D Request for Proposals (RFP)''. (0128)

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