UNIVERSITY OF FLORIDA
Grant: $308,882 - National Institutes of Health - Sep. 7, 2009
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Award Description: The arteriovenous fistula (AVF) is the preferred mode of vascular access for chronic hemodialysis, because of significantly lower mortality, morbidity, and maintenance costs as compared to other types of access. However, recent reports establish that as many as 60% of surgically-created AVFs fail to mature (i.e., increase in luminal diameter and blood flow rate) adequately to support hemodialysis. The clinical and economic costs of these failures are very high. The Hemodialysis Fistula Maturation Consortium (HFMC), with 6 Clinical Centers (CCs) and a Data Coordinating Center, was funded by NIDDK U01 awards in September 2008 to identify risk factors for maturation failure, and assess vascular imaging and other measures as possible surrogate outcomes for future vascular access clinical trials. The HFMC plans to enroll 600 subjects, over 27 months starting October 1, 2009, in a prospective cohort study. Predictors will include pre-operative clinical and ultrasound (US) measures and surgical data. To explore surrogacy, post-operative US will be conducted at 6 weeks, and at later time points for AVFs that have not been used by 10 weeks. This proposal requests an administrative supplement to allow the Univ. of Florida CC to enroll 100 subjects in 18 instead of 27 months (Specific Aim 1), and to include pre-operative vascular function tests and venous sample analysis (Specific Aim 2), and early (1-day and 2-week) post-operative US (Specific Aim 3). Aim 1 will accelerate the acquisition of pre-operative and early post-operative data that will be highly enriched by the measures in Aims 2 and 3; double minimum follow-up time; allow direct observation of AVF use in more subjects; and increase data on AVF reliability and longevity by 20-30%. The studies in Aims 2 and 3 include potentially important predictors of maturation failure envisioned in the RFA and endorsed by the HFMC Steering Committee before ARRA, but which are not affordable with current funding. These studies will allow the testing of specific plausible mechanisms of AVF maturation failure by relating specific predictors, including pre-operative vascular function and histological measures (Aim 2) to (a) early post-operative vascular responses reflected in the 1-day and 2-week US measures and trajectories (Aim 3), and (b) clinical AVF maturation (assessed as part of the parent study). The tasks proposed are 'shovel-ready' and will be completed within 2 years, since the anticipated timing of supplement awards is close to the start-up of the HFMC study. Personnel constitute most of the direct costs requested.
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