Status:
COMPLETED
Examining the Effects of Mitochondrial Oxidative Stress in DCM
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
British Heart Foundation
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
Double blind, randomised, placebo-controlled trial of MitoQ (mitoquinol mesylate) in 106 patients with dilated cardiomyopathy, examining the effect of reducing mitochondrial oxidative stress on myocar...
Eligibility Criteria
Inclusion
- Inclusion criteria
- idiopathic or familial DCM
- LVEF ≤45% on 2 imaging studies of any modality ≥3 months apart (may include CMR scan at baseline visit)
- on guideline therapy for ≥3 months as determined by usual clinicians
- sinus rhythm on 12-lead electrocardiogram
- plasma NT-pro-BNP \>250ng/L for those \>65 years and \>100ng/L for those aged ≤65 years within the last 6 months (may include sample at baseline visit)
- Exclusion criteria
- current persistent atrial fibrillation
- contraindication to CMR
- estimated glomerular filtration rate (eGFR) \<30mls/min
- current or planned pregnancy or current breast-feeding
- clear environmental trigger such as excess alcohol intake, cardiotoxic chemotherapy or peripartum presentation
- fibrosis burden \>25% on CMR
- current cancer (other than non-melanoma skin cancers)
- current use of CoQ10
- current participation in another randomised controlled trial
Exclusion
Key Trial Info
Start Date :
July 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2024
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05410873
Start Date
July 26 2022
End Date
June 19 2024
Last Update
September 18 2025
Active Locations (1)
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1
Royal Brompton Hospital
London, United Kingdom