Examining the Effects of Mitochondrial Oxidative Stress in DCM

Phase 2

Recruiting

• Conditions: Dilated Cardiomyopathy
• Interventions: Drug: Placebo; Drug: MitoQ Compound

• Registration Number: NCT05410873
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Study Start: 2022-07-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-21
• Primary Completion: 2025-01-03
• Study Completion: 2025-07-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
MitoQ	MitoQ Compound	Mitoquinol mesylate 40mg daily

Primary Outcome Measures

Name	Time	Method
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
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
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

Name	Time	Method
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
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
Follow-on phase - change in renal function	12 months	Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients
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
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
Follow-on phase - change in symptom burden	12 months	Change in symptom score between baseline and follow-up amongst all 106 patients
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
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

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom