NCT03188978: HAFF

High-intensity Atorvastatin for Arteriovenous Fistula Failure (HAFF): A Feasibility Pilot Study

Withdrawn Phase 1, PHASE2 Last updated 18 January 2020

What this trial tests

Phase 1, PHASE2 trial testing Atorvastatin 40mg in Primary Arteriovenous Fistula Failure. Withdrawn.

Timeline

1 November 2018

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Albany Medical College
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Start date	1 November 2018
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across United States

Drugs / interventions tested

• Atorvastatin 40mg — full drug profile →
• Placebo

Conditions studied

• Primary Arteriovenous Fistula Failure — all drugs for Primary Arteriovenous Fistula Failure →

Sponsor

Albany Medical College

Who can join

19 and older, any sex, with Primary Arteriovenous Fistula Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Somatic Variant Analysis Identifies Targets for Tailored Therapies in Patients with Vascular Malformations.
   Paolacci S, Mattassi RE, Marceddu G, Manara E, et al · · 2020 · cited 8× · PMID 33105631 · DOI 10.3390/jcm9113387
2. Cellular and molecular mechanisms underlying hemodialysis arteriovenous fistula dysfunction and approaches to promote maturation: a vascular perspective.
   Shiu YT, Northrup H, Huang Y, Cho ME, et al · · 2025 · cited 7× · PMID 40465509 · DOI 10.1152/ajpheart.00010.2025