A -- Phase II/III Trial of Sildenafil for Sickle Cell Disease-Associated Pulmonary Hypertension - Clinical Sites

The NHLBI has a requirement for a study to test the effects of 16 weeks of chronic sildenafil therapy on exercise endurance and pulmonary artery pressure in 180 patients (aged 14 and up) with pulmonary hypertension (PH) and Sickle Cell Disease (SCD). The successful offeror will operate as a clinical site for this clinical trial. Each clinical site shall be responsible for performing the following tasks: 1) Participate in the finalization of the protocol; 2) Obtain Institutional Review Board (IRB) approval of the final study protocol and informed consent forms; 3) Participate with other members of the steering committee in the development and writing of the Manual of Procedures (MOP); 4) Cooperate with the Data Coordinating Center and NHLBI Project Officer to develop the official Case Report Forms for this study; 5) Obtain informed consent for patient enrollment. Perform all procedures as indicated in the schedule of the final protocol. Follow and monitor patients as outlined in the protocol. Enter study data on Case Report Forms (paper or electronic) for each patient entered into the study; 6) Screen a minimum of 84 subjects for PH in accordance with the final protocol. The subjects screened shall be children and adults, age 14 or older, and with a diagnosis (based on hemoglobin electrophoresis) of sickle cell disease- Hb SS, SC, SD, or S/beta0/+-thalassemia. At least 60 of these subjects shall be adults (age 18 or older); 7) Enroll at least 15 subjects with documented PH (based on screening results) into the main protocol; 8) For each patient screened in the study, collect and ship at least one sample of fresh plasma and at least one sample of whole blood (for DNA extraction) to the NHLBI Biological Specimen Repository; 9) Perform hemodynamic measurements via right heart catheterization on at least 7 subjects with severe PH in accordance with the final protocol; and 10) Oversee exit of the trial subjects from the clinical trial and counsel patients regarding access to drug after drug supply is exhausted. The government intends to negotiate up to twelve cost reimbursement type contracts for a period of four years with an approximate award date of September 30, 2006. A Data Coordinating Center will be awarded under a separate Request For Proposals (RFP). This is not a RFP. RFP NHLBI-HB-06-06 will be available on or about October 5, 2005, and may be accessed at the following URL location: http://www.nhlbi.nih.gov/funding/inits/index.htm#rfp and posted on Fed Biz Opps at http://fedbizopps.gov . No paper copies will be available. Original Point of Contract Rick Phillips, Contracting Officer, Phone (301) 402-6462, Fax (301) 480-3432, E-mail phillipr@nhlbi.nih.gov or Joanna Magginas, Chief, BDR Contracts Section, Phone (301) 435-0355, Fax (301) 480-3432, E-mail magginaj@nhlbi.nih.gov