Examining the Effects of Mitochondrial Oxidative Stress in DCM

• Status: Not yet recruiting
• Trial end date: 2025-07-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborator: British Heart Foundation

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