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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Mitoquinol mesylate
Placebo
Royal Brompton Hospital
London, United Kingdom
Vanguard phase - change in myocardial PCr:ATP
The first 34 patients will enter a 3 months Vanguard phase. Change in myocardial PCr:ATP between baseline and follow-up will be measured using 31P magnetic resonance spectroscopy
Time frame: 3 months
Vanguard phase - change in circulating markers of oxidative stress
The first 34 patients will enter a 3 months Vanguard phase. Change in circulating oxLDL and F2isoprostanes will be measured in plasma samples
Time frame: 3 months
Primary outcome - change in LVESVi
Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time frame: 12 months
Vanguard phase - change in skeletal muscle PCr recovery
The first 34 patients will enter a 3 months Vanguard phase. Change in skeletal muscle PCr recovery between baseline and follow-up will be measured using 31P magnetic resonance spectroscopy
Time frame: 3 months
Follow-on phase - change in LVEF
Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time frame: 12 months
Follow-on phase - change in LVEDVi
Change in LVEDVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time frame: 12 months
Follow-on phase - change in GLS
Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months
Follow-on phase - change in NT-pro-BNP
Change in plasma concentrations of NT-pro-BNP (ng/L) between baseline and follow-up amongst all 106 patients
Time frame: 12 months
Follow-on phase - change in renal function
Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients
Time frame: 12 months
Follow-on phase - change in symptom burden
Change in symptom score between baseline and follow-up amongst all 106 patients
Time frame: 12 months
Follow-on phase - change in exercise capacity
Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients
Time frame: 12 months