Full Text PA-95-003 CLINICAL TRIALS USING TIPS PROCEDURE FOR PORTAL HYPERTENSION NIH GUIDE, Volume 23, Number 37, October 21, 1994 PA NUMBER: PA-95-003 P.T. 34 Keywords: Hypertension Clinical Trial National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The purpose of this Program Announcement (PA) is to encourage investigators in digestive diseases to undertake prospective, randomized, controlled, long-term follow-up, multicenter clinical trials on the nonsurgical procedure, transjugular intrahepatic portosystemic shunt (TIPS) placement in the management of portal hypertension, variceal bleeding, and ascites. The procedure is already being performed for these indications, even though it has not been compared sufficiently with standard treatments such as sclerotherapy, pharmacologic therapy, and various forms of surgical shunting for efficacy, patient acceptance, safety and cost benefit. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," in a PHS-led national activity for setting priority areas. This PA, Clinical Trials Using TIPS Procedure for Portal Hypertension, is related to the priority area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT Support for this Program Announcement will be through the NIH research project grant (R01). FUNDS AVAILABLE The direct cost should not exceed $500,000 in the first budget period. RESEARCH OBJECTIVES The TIPS procedure has recently been introduced as a treatment of portal hypertension, variceal bleeding and ascites. The National Digestive Diseases Advisory Board recently sponsored a conference on the role of TIPS for treatment of portal hypertension and its complications. In summary of the conference, the TIPS procedure is a new and exciting modality for treatment of portal hypertension and its complications. It is thus beneficial in the medical management of patients with acute variceal hemorrhage. However, indications for TIPS remain to be better defined in terms of efficacy and cost- benefit in relationship to other established modes of therapy of portal hypertension. TIPS is an invasive procedure and is associated with several potential complications. Placement of TIPS has an acute mortality rate of approximately one percent and a serious complication rate of 3 to 10 percent. Thus, prospective, randomized controlled clinical trials with long-term follow-up for the prevention and treatment of rebleeding esophageal varices comparing the TIPS procedure with standard therapies, i.e., sclerotherapy, pharmacologic therapy, and surgical shunting, are needed. An example of a specific clinical trial could be the comparison of the TIPS procedure with surgical shunting for prevention of rebleeding in patients who have recurrent variceal bleeding despite conventional medical therapies. In addition, a well-defined study in patients with refractory ascites is needed to compare TIPS with the standard therapy such as large-volume paracentesis. At present, long-term efficacy of TIPS is related to shunt patency. For the first year after undergoing the procedure, delayed stenosis or occlusion of the shunt has been reported in 33 to 66 percent of the patients. The pathological process results from endothelial hyperplasia and collagen deposition within the stent. Studies evaluating means of monitoring for stenosis and dilation of narrowed stents are also needed. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All applications proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institute of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title and number of this program announcement must be typed in Section 2a on the face page of the application. These will be accepted at the regular application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Institute of Diabetes and Digestive and Kidney Diseases. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Administrative suggestions for preparing an R01 clinical trial grant application that include review criteria for clinical trials and, also, the summary of the recently held TIPS conference are available. Direct inquiries regarding programmatic issues to: Ms. Tommie Sue Tralka Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 3A15 45 CENTER DR MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7592 Email: S2T@CU.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Paulette Badman Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 45 Center Drive MSC 6600 Bethesda, MD 208920-6600 Telephone: (301) 594-7543 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99- 158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |