Last reviewed · How we verify

NCT05256758: OxFAST

Oxford - Fibrates in Aortic Stenosis

Status unknown NA Last updated 25 February 2022
What this trial tests

NA trial testing Fenofibrate Capsules in Aortic Valve Stenosis in 67 participants. Status unknown.

Timeline
29 May 2019
Primary endpoint
31 March 2022
31 March 2022

Quick facts

Lead sponsorUniversity of Oxford
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment67
Start date29 May 2019
Primary completion31 March 2022
Estimated completion31 March 2022
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Oxford

Who can join

18 and older, any sex, with Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aortic stenosis (AS) is characterised by left ventricular (LV) hypertrophy and altered myocardial substrate metabolism. Peroxisome proliferator-activated receptor (PPARα), a regulator of lipid metabolism is deactivated in pressure overload hypertrophy such as in AS and can lead to dysregulation of fatty acid oxidation, myocardial triglyceride accumulation (steatosis) and lipotoxicity. The investigators propose a proof-of-concept study to investigate the effect of altering myocardial triglyceride (MTG) using a PPARα agonist, fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. The primary endpoint is a change in MTG assessed by magnetic resonance spectroscopy at baseline and after 6 months of treatment. Exploratory endpoints are changes in cardiac physiology including myocardial deformation (strain) as assessed by cardiac magnetic resonance imaging. The investigators hypothesise that pharmacological reduction of MTG with a PPARα agonist will result in steatosis regression and changes in cardiac physiology.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Role of Cardiac Energetics in Aortic Stenosis Disease Progression: Identifying the High-risk Metabolic Phenotype.
    Monga S, Valkovič L, Myerson SG, Neubauer S, et al · · 2023 · cited 5× · PMID 37847766 · DOI 10.1161/circimaging.122.014863

Verify or expand the search:

Other recruiting trials for Aortic Valve Stenosis

Currently open trials in the same condition.

Other University of Oxford trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05256758.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing