Examining the Effects of Mitochondrial Oxidative Stress in DCM

NCT ID: NCT05410873

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-26

Study Completion Date

2024-06-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dilated Cardiomyopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MitoQ

Mitoquinol mesylate 40mg daily

Group Type EXPERIMENTAL

MitoQ Compound

Intervention Type DRUG

Mitoquinol mesylate

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MitoQ Compound

Mitoquinol mesylate

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. idiopathic or familial DCM
2. LVEF ≤45% on 2 imaging studies of any modality ≥3 months apart (may include CMR scan at baseline visit)
3. on guideline therapy for ≥3 months as determined by usual clinicians
4. sinus rhythm on 12-lead electrocardiogram
5. 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

1. current persistent atrial fibrillation
2. contraindication to CMR
3. estimated glomerular filtration rate (eGFR) \<30mls/min
4. current or planned pregnancy or current breast-feeding
5. clear environmental trigger such as excess alcohol intake, cardiotoxic chemotherapy or peripartum presentation
6. fibrosis burden \>25% on CMR
7. current cancer (other than non-melanoma skin cancers)
8. current use of CoQ10
9. current participation in another randomised controlled trial
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

British Heart Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Brian Halliday, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London and Royal Brompton Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21IC6593

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.