Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial

K Lindhard; M Rix; J G Heaf; H P Hansen; B L Pedersen; B L Jensen; D Hansen

doi:10.1186/s12882-021-02476-x

Effect of far infrared therapy on arteriovenous fistula maturation, survival and stenosis in hemodialysis patients, a randomized, controlled clinical trial: the FAITH on fistula trial

BMC Nephrol. 2021 Aug 21;22(1):283. doi: 10.1186/s12882-021-02476-x.

Authors

K Lindhard¹, M Rix², J G Heaf³, H P Hansen⁴, B L Pedersen⁵, B L Jensen⁶, D Hansen⁴

Affiliations

¹ Department of Nephrology, Herlev Hospital, Borgmester Ib Juels Vej 1, DK-2730, Herlev, Denmark. Kristine.lindhard.rasmussen@regionh.dk.
² Department of Nephrology, Rigshospitalet, Copenhagen, Denmark.
³ Department of Nephrology, University hospital of Zealand, Roskilde, Denmark.
⁴ Department of Nephrology, Herlev Hospital, Borgmester Ib Juels Vej 1, DK-2730, Herlev, Denmark.
⁵ Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark.
⁶ Department of cardiovascular and renal research, University Hospital of Southern Denmark, Odense, Denmark.

Abstract

Background: An arteriovenous fistula (AVF) is the preferred vascular access for hemodialysis treatment. After creation many of the AVFs will never mature or if functioning will need an intervention within 1 year due to an AVF stenosis. Studies investigating possible therapies that improves the AVF maturation and survival are scarce. Far infrared therapy (FIR) has shown promising results. In minor single centre and industry supported trials FIR has shown improved AVF maturation and survival. There is a need of a randomized multicentre controlled trial to examine the effect of FIR on the AVF maturation and survival and to explore the possible AVF protective mechanism induced by the FIR treatment.

Methods: This investigator initiated, randomized, controlled, open-labeled, multicenter clinical trial will examine the effect of FIR on AVF maturation in patients with a newly created AVF (incident) and AVF patency rate after 1 year of treatment in patients with an existing AVF (prevalent) compared to a control group. The intervention group will receive FIR to the skin above their AVF three times a week for 1 year. The control group will be observed without any treatment. The primary outcome for incident AVFs is the time from surgically creation of the AVF to successful cannulation. The primary outcome for the prevalent AVFs is the difference in number of AVFs without intervention and still functioning in the treatment and control group after 12 months. Furthermore, the acute changes in inflammatory and vasodilating factors during FIR will be explored. Arterial stiffness as a marker of long term AVF patency will also be examined.

Discussion: FIR is a promising new treatment modality that may potentially lead to improved AVF maturation and survival. This randomized controlled open-labelled trial will investigate the effect of FIR and its possible mechanisms.

Trial registration: Clinicaltrialsgov NCT04011072 (7th of July 2019).

Keywords: AVF maturation; AVF patency; Arteriovenous fistula; Hemodialysis; Infrared therapy.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Arteriovenous Shunt, Surgical*
Catheterization* / methods
Constriction, Pathologic / radiotherapy
Humans
Infrared Rays*
Kidney Failure, Chronic* / therapy
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Renal Dialysis*
Vascular Patency

Associated data

ClinicalTrials.gov/NCT04011072