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FBO DAILY ISSUE OF JULY 04, 2009 FBO #2777
SOLICITATION NOTICE

A -- Randomized Evaluation of VAD InterVEntion before Inotropic Therapy

Notice Date
7/2/2009
 
Notice Type
Presolicitation
 
NAICS
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 
ZIP Code
20892-7902
 
Solicitation Number
NHLBI-HV-10-14
 
Archive Date
7/31/2009
 
Point of Contact
Pam McCord-Reynolds, Phone: 301-435-0340, Joanne F Deshler, Phone: (301) 435-0340
 
E-Mail Address
mccordreynoldp@nhlbi.nih.gov, deshlerj@nhlbi.nih.gov
(mccordreynoldp@nhlbi.nih.gov, deshlerj@nhlbi.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
Introduction The National Institutes of Health (NIH), National Heart Lung, and Blood Institutes (NHLBI), Office of Acquisitions (OA), will be seeking proposals from qualified organizations with the ability to serve as a Data Coordinating Center (DCC) capable of conducting all aspects (administrative guidance, oversight, and support) of a multi-center Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT) feasibility clinical study. This acquisition has not been designated a type of set aside, this information will be available upon solicitation posting. It is anticipated that one (1) cost-reimbursement contract award for a period of five years will be made. THIS PRESOLICITATION NOTICE IS NOT THE REQUEST FOR PROPOSALS (RFP); the Request For Proposals will be available on or about July 23, 2009. The estimated due date for proposals is December 9, 2009. Background The purpose of this clinical feasibility study is to explore the potential benefit of mechanical circulatory support therapy using ventricular assist devices (VADs) in functionally-impaired advanced heart failure patients who have not yet developed serious consequences from their disease. The study will serve to inform a pivotal trial directed at a large and growing patient population for whom VADs could offer substantial benefit beyond current medical therapies. Project Requirements The clinical study to be developed will test the hypothesis that VAD therapy improves both survival and quality of life in those advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. The recommendations made by the NHLBI Working Group on the Clinical Use of VADs are given below. • Study hypothesis: VAD therapy in the proposed patient population will improve functional status at 12 months post-randomization and all cause mortality will be no worse than that in the optimal medical management arm of the study. • Patients for the study should be ill enough to potentially experience both functional and survival benefits from the therapy without undue risk. • The estimated mortality rate for this group should be 20%- 30% at one year. • Patient Population Inclusion Criteria includes (1) hospitalization in past 6 months, (2) NYHA Class IV or Advanced Class III, (3) maximal evidence-based therapies for 3 months, (4) duration of heart failure of at least a year, and (5) no inotropic support for 30 days prior to enrollment. • The study should be randomized between VAD and optimal medical management (OMM) arms • The primary endpoint should be a composite of survival and functional status where the improvement in functional status would need to be substantial and assessed through objective metrics. • Secondary endpoints are safety, secondary functional and physiologic markers, quality of life, neurocognition, and cost and cost effectiveness. • Patients should be followed for at least two years. • Substantial evidence of acceptable clinical performance is required for VADs to be used in the study. The DCC is expected to develop the clinical study plan (including specific inclusion/exclusion criteria and rationale, device(s) for the VAD therapy arm of the clinical study, adverse event definitions, and functional, quality of life, and neurocognitive measures), a draft protocol, negotiate and obtain signed contracts/agreements with clinical sites and industry partners. Required activities by the DCC include, but are not limited to, (1) finalizing all details of the clinical study to provide evidence for the proposed hypothesis and to assess recruitment and data quality; (2) finalizing the clinical protocol and protocol-related documents (e.g. informed consent form, case report forms, etc.); (3) implementation and conduct of the clinical study in accordance with all Federal requirements; (4) management and oversight of the conduct of the clinical study; (5) providing clinical research support services; (6) providing monitoring and safety oversight; (7) providing site training and support; (8) organizing investigator and DSMB meetings and teleconferences; (9) recruiting and randomizing patients; (10) organizing, conducting, and reimbursing for patient protocol evaluations and tests (including follow-up); and (11) analyzing the data and authoring and submitting papers on the study for publication.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HV-10-14/listing.html)
 
Place of Performance
Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, MD,, Maryland, 20892-7902, United States
Zip Code: 20892-7902
 
Record
SN01864784-W 20090704/090703001333-171de254b47df97fccc1cadcb51f908a (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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