Examining the effects of a compound on heart function in patients with dilated cardiomyopathy
Examining the Effects of Mitochondrial Oxidative Stress in DCM
PHASE2 · Imperial College London · NCT05410873
This study is testing whether a new compound called MitoQ can improve heart function in people with dilated cardiomyopathy by reducing stress on their heart cells.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Trial ID | NCT05410873 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, randomized, placebo-controlled trial involving 106 patients diagnosed with dilated cardiomyopathy (DCM). The study aims to assess the impact of MitoQ (mitoquinol mesylate) on reducing mitochondrial oxidative stress and its subsequent effects on myocardial energetics and function. Participants will undergo 31-phosphorus magnetic resonance spectroscopy and cardiovascular magnetic resonance to evaluate these effects over the course of the trial.
Who should consider this trial
Good fit: Ideal candidates include individuals with idiopathic or familial dilated cardiomyopathy and reduced left ventricular ejection fraction.
Not a fit: Patients with persistent atrial fibrillation or significant renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve heart function and overall health outcomes for patients with dilated cardiomyopathy.
How similar studies have performed: Previous studies have shown promise in targeting mitochondrial oxidative stress, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Royal Brompton Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Brian Halliday, MBChB PhD — Imperial College London and Royal Brompton Hospital
- Study coordinator: Lindsay Smith
- Email: mitoDCM@imperial.ac.uk
- Phone: 02073528121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dilated Cardiomyopathy, Energetics, Mitochondria, Oxidative stress