High-intensity Atorvastatin for Arteriovenous Fistula Failure (HAFF): A Feasibility Pilot Study
Status:
Withdrawn
Trial end date:
2019-12-31
Target enrollment:
Participant gender:
Summary
Primary failure is the most common complication of newly created arteriovenous fistulas
(AVFs) and an important contributor to end stage renal disease (ESRD) patients' morbidity and
mortality. Recently, the investigators have found that high intensity atorvastatin (40
mg/day) reduces AVF primary failure significantly when compared to other statins or no statin
treatment in three separate prospective and retrospective studies done in collaboration with
the University of Miami. Based on these findings and considering the necessity for a therapy
to improve AVF maturation rates, the investigators propose the realization of a feasibility
pilot double blinded randomized controlled trial (RCT). In this study, a total of 50 patients
will be randomly allocated to receive high intensity atorvastatin (40 mg daily) or placebo
starting at two weeks before surgery and until the end of the observational period (6 weeks
after surgery). Present trial will reveal crucial feasibility information such as the
appropriateness of the eligibility criteria, patient recruitment and retention rates,
compliance, adverse events, efficacy of patient follow-ups, and readiness of the facilities
and involved personnel; while having as a secondary endpoint the predictive measurements of
diameter and AVF blood flow 6 weeks after fistula creation useful for the estimation of the
probable effect of proposed intervention. Here, the investigators aim to pave the way for a
future multicenter Phase II RCT seeking to prove the efficacy of atorvastatin therapy as a
perioperative intervention to reduce AVF primary failure.