NIH GUIDE, Volume 25, Number 17, May 24, 1996




P.T. 34


  Clinical Trial 

  Pulmonary Diseases 


National Heart, Lung, and Blood Institute


The National Heart, Lung, and Blood Institute (NHLBI) of the National

Institutes of Health (NIH) and the Health Care Financing

Administration (HCFA) 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 will be released for the clinical coordinating center.

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) 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 to 30 percent 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 HCFA will pay all allowable clinical costs for

its beneficiaries.




This is not an RFP.  RFP NHLBI-HR-97-02 will be available on or about

June 3, 1996, with proposals due on or about August 5, 1996.  Award

of a contract for this study will be made only to offerors located in

the United States of America.  The RFP will be available on the NIH

Gopher.  Access via the NIH Website (  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

can access the RFP by pointing your gopher client to GOPHER.NIH.GOV/.

Select "Grant and Research Information", then select "R&D Request for

Proposals (RFP)".  The RFP may also be obtained by writing to:


Joanne C. Deschler

HLVD Contracts Section

National Heart, Lung, and Blood Institute

6701 Rockledge Drive, MSC 7902

Bethesda, MD  20892



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