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Completed

NCT Number: NCT05410873

Examining the Effects of Mitochondrial Oxidative Stress in DCM

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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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brompton Hospital

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MitoQ Compound

Drug

Mitoquinol mesylate

Placebo

Drug

Placebo

Primary outcomes

  1. Vanguard phase - change in myocardial PCr:ATP

    Time frame: 3 months

    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

  2. Vanguard phase - change in circulating markers of oxidative stress

    Time frame: 3 months

    The first 34 patients will enter a 3 months Vanguard phase. Change in circulating oxLDL and F2isoprostanes will be measured in plasma samples

  3. Primary outcome - change in LVESVi

    Time frame: 12 months

    Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

Secondary outcomes

  1. Vanguard phase - change in skeletal muscle PCr recovery

    Time frame: 3 months

    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

  2. Follow-on phase - change in LVEF

    Time frame: 12 months

    Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

  3. Follow-on phase - change in LVEDVi

    Time frame: 12 months

    Change in LVEDVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

  4. Follow-on phase - change in GLS

    Time frame: 12 months

    Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

  5. Follow-on phase - change in NT-pro-BNP

    Time frame: 12 months

    Change in plasma concentrations of NT-pro-BNP (ng/L) between baseline and follow-up amongst all 106 patients

  6. Follow-on phase - change in renal function

    Time frame: 12 months

    Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients

  7. Follow-on phase - change in symptom burden

    Time frame: 12 months

    Change in symptom score between baseline and follow-up amongst all 106 patients

  8. Follow-on phase - change in exercise capacity

    Time frame: 12 months

    Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • British Heart Foundation

Registry information

Acronym: MitoDCM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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