MitoDCM: Examining the Effects of Mitochondrial Oxidative Stress in DCM

• Sponsor: Imperial College London (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05410873
• Collaborator: British Heart Foundation (Other)
• Enrollment: 106
• Arms: 2
• Anticipated Duration (Months): 35.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dilated Cardiomyopathy	Drug: MitoQ Compound; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Examining the Effects of Mitochondrial Oxidative Stress in DCM
• Anticipated Study Start Date: Jul 18, 2022
• Anticipated Primary Completion Date: Jan 3, 2025
• Anticipated Study Completion Date: Jul 3, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MitoQ Mitoquinol mesylate 40mg daily	Drug: MitoQ Compound; Mitoquinol mesylate
Placebo Comparator: Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Vanguard phase - change in myocardial PCr:ATP [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

2. Vanguard phase - change in circulating markers of oxidative stress [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

3. Primary outcome - change in LVESVi [12 months]

   Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

Secondary Outcome Measures

1. Vanguard phase - change in skeletal muscle PCr recovery [3 months]

   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

2. Follow-on phase - change in LVEF [12 months]

   Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

3. Follow-on phase - change in LVEDVi [12 months]

   Change in LVEDVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

4. Follow-on phase - change in GLS [12 months]

   Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance

5. Follow-on phase - change in NT-pro-BNP [12 months]

   Change in plasma concentrations of NT-pro-BNP (ng/L) between baseline and follow-up amongst all 106 patients

6. Follow-on phase - change in renal function [12 months]

   Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients

7. Follow-on phase - change in symptom burden [12 months]

   Change in symptom score between baseline and follow-up amongst all 106 patients

8. Follow-on phase - change in exercise capacity [12 months]

   Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Imperial College London
• British Heart Foundation

Investigators

• Principal Investigator: Brian Halliday, MBChB PhD, Imperial College London and Royal Brompton Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT05410873
• Other Study ID Numbers: 21IC6593
• First Posted: Jun 8, 2022
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Energetics; Mitochondria; Oxidative stress
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated

Study Results

No Results Posted as of Jun 13, 2022