Status:
UNKNOWN
Oxford - Fibrates in Aortic Stenosis
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
British Heart Foundation
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aortic stenosis (AS) is characterised by left ventricular (LV) hypertrophy and altered myocardial substrate metabolism. Peroxisome proliferator-activated receptor (PPARα), a regulator of lipid metabol...
Detailed Description
This is a single-centre, proof-of-concept study to investigate the effect of altering MTG content using fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. All patients...
Eligibility Criteria
Inclusion
- Asymptomatic moderate to severe AS (with at least two of the following: aortic valve area \<1.5 cm2, peak pressure gradient \>36 mmHg or mean pressure gradient \>25 mmHg)
- Not planned aortic valve replacement or transcatheter aortic valve implantation (TAVI)
- Age \>18
- No other significant valvular pathology
- No contraindication to magnetic resonance imaging.
Exclusion
- Known coronary artery disease, history of angina, myocardial infarction or presence of regional wall motion abnormalities
- Other underlying cardiomyopathy
- Left ventricular ejection fraction\<50%
- Uncontrolled hypertension
- Diabetes Mellitus
- Liver impairment
- Pregnancy and lactation
- Body mass index \>35 kg/m2
- Renal impairment (eGFR\<30 ml/min)
- Intolerance to or concurrent use of fibrates or PPARα agonists.
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT05256758
Start Date
May 29 2019
End Date
March 31 2022
Last Update
February 25 2022
Active Locations (1)
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1
OUH NHS trust
Oxford, United Kingdom, OX3 9DU