Examining the Effects of Mitochondrial Oxidative Stress in DCM

Dilated Cardiomyopathy Clinical Trial

— MitoDCM  

Official title:

Examining the Effects of Mitochondrial Oxidative Stress in DCM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410873
• Other study ID #: 21IC6593
• Status: Recruiting
• Phase: Phase 2
• Start date: July 26, 2022
• Est. completion date: July 3, 2025

Study information

• Verified date: September 2022
• Source: Imperial College London
• Contact: Lindsay Smith
• Phone: 02073528121
• Email: mitoDCM[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 resonance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: July 3, 2025
• Est. primary completion date: January 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

Drug:
• MitoQ Compound
Mitoquinol mesylate
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Primary	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	3 months
Primary	Primary outcome - change in LVESVi	Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance	12 months
Secondary	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	3 months
Secondary	Follow-on phase - change in LVEF	Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance	12 months
Secondary	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	12 months
Secondary	Follow-on phase - change in GLS	Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance	12 months
Secondary	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	12 months
Secondary	Follow-on phase - change in renal function	Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients	12 months
Secondary	Follow-on phase - change in symptom burden	Change in symptom score between baseline and follow-up amongst all 106 patients	12 months
Secondary	Follow-on phase - change in exercise capacity	Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients	12 months