Examining the Effects of Mitochondrial Oxidative Stress in DCM

NCT05410873 | Completed Phase 2 DMC

• 1 other identifier: 21IC6593
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Dilated Cardiomyopathy

Keywords

Energetics; Mitochondria; Oxidative stress

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (8)

• Vanguard phase - change in skeletal muscle PCr recovery

  3 months

• Follow-on phase - change in LVEF

  12 months

• Follow-on phase - change in LVEDVi

  12 months

• Follow-on phase - change in GLS

  12 months

• Follow-on phase - change in NT-pro-BNP

  12 months

Study Arms (2)

MitoQ

EXPERIMENTAL

Mitoquinol mesylate 40mg daily

Drug: MitoQ Compound

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MitoQ Compound DRUG

Mitoquinol mesylate

MitoQ

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• British Heart Foundation: collaborator

Study Sites (1)

Royal Brompton Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Halliday, MBChB PhD

  Imperial College London and Royal Brompton Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: July 26, 2022
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

GB (1)