Dilated CardiomyopathyPhase 2MitoDCMNCT05410873
Examining the Effects of Mitochondrial Oxidative Stress in DCM
A Phase 2 study testing MitoQ Compound in people with Dilated Cardiomyopathy, run by Imperial College London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- MitoQ Compound
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jul 2022to 19 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- current cancer (other than non-melanoma skin cancers)
- current use of CoQ10
- current participation in another randomised controlled trial
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- MitoQ Compound, Placebo
- Keywords
- Energetics, Mitochondria, Oxidative stress
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoQ CompoundDrug
Mitoquinol mesylate
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MitoQ | Experimental | Mitoquinol mesylate 40mg daily Receives: Drug: MitoQ Compound |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 12 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Follow-on phase - change in renal function
Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients
Measured: 12 months
Follow-on phase - change in symptom burden
Change in symptom score between baseline and follow-up amongst all 106 patients
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start26 Jul 2022
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Brian Halliday, MBChB PhD, Principal investigator, Imperial College London and Royal Brompton Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410873
- Sponsor's protocol ID
- 21IC6593
- Acronym
- MitoDCM
- Status last verified
- Sep 2025
- First submitted
- 6 Jun 2022
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Mitochondrial Oxidative Stress in DCM
- ClinicalTrials.gov ID
- NCT05410873
- Acronym / sponsor ID
- MitoDCM / 21IC6593
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Energetics, Mitochondria, Oxidative stress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MitoQ | Experimental | Drug: MitoQ CompoundMitoquinol mesylate 40mg daily |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitoQ CompoundMitoquinol mesylate | Drug | MitoQ |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
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
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
8 secondary outcomes
Vanguard phase - change in skeletal muscle PCr recovery
Time frame: 3 months
Follow-on phase - change in LVEF
Time frame: 12 months
Follow-on phase - change in LVEDVi
Time frame: 12 months
Follow-on phase - change in GLS
Time frame: 12 months
Follow-on phase - change in NT-pro-BNP
Time frame: 12 months
Follow-on phase - change in renal function
Time frame: 12 months
Follow-on phase - change in symptom burden
Time frame: 12 months
Follow-on phase - change in exercise capacity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Halliday, MBChB PhD principal investigator
Imperial College London and Royal Brompton Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MitoQ Compound in people with Dilated Cardiomyopathy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vanguard phase - change in myocardial PCr:ATP (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.