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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MitoQ | Experimental | Mitoquinol mesylate 40mg daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitoQ Compound | Drug | Mitoquinol mesylate |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Follow-on phase - change in LVEF |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brian Halliday, MBChB PhD | Imperial College London and Royal Brompton Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | United Kingdom |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ID | Term |
|---|---|
| C429014 | mitoquinone |
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| Drug |
Placebo |
|
Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance |
| 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 | 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 | 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 | 12 months |
| Follow-on phase - change in renal function | Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients | 12 months |
| Follow-on phase - change in symptom burden | Change in symptom score between baseline and follow-up amongst all 106 patients | 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 | 12 months |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |