CompletedPhase 2

Examining the Effects of Mitochondrial Oxidative Stress in DCM

United Kingdom53 participantsStarted 2022-07-26

Plain-language 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 myocardial energetics and myocardial function using 31-phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance.

Who can participate

Age range16 Years

SexALL

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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

What they're measuring

Vanguard phase - change in myocardial PCr:ATP

Timeframe: 3 months

Vanguard phase - change in circulating markers of oxidative stress

Timeframe: 3 months

Primary outcome - change in LVESVi

Timeframe: 12 months

Trial details

NCT IDNCT05410873

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-19

View on ClinicalTrials.gov More Dilated Cardiomyopathy trials