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Examining the Effects of Mitochondrial Oxidative Stress in DCM (MitoDCM)

Primary Purpose

Dilated Cardiomyopathy

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
MitoQ Compound
Placebo
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring Energetics, Mitochondria, Oxidative stress

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Brompton HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MitoQ

Placebo

Arm Description

Mitoquinol mesylate 40mg daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Follow-on phase - change in LVEF
Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
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
Follow-on phase - change in GLS
Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
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
Follow-on phase - change in renal function
Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients
Follow-on phase - change in symptom burden
Change in symptom score between baseline and follow-up amongst all 106 patients
Follow-on phase - change in exercise capacity
Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients

Full Information

First Posted
June 6, 2022
Last Updated
September 16, 2022
Sponsor
Imperial College London
Collaborators
British Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05410873
Brief Title
Examining the Effects of Mitochondrial Oxidative Stress in DCM
Acronym
MitoDCM
Official Title
Examining the Effects of Mitochondrial Oxidative Stress in DCM
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
July 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
British Heart Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
Energetics, Mitochondria, Oxidative stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MitoQ
Arm Type
Experimental
Arm Description
Mitoquinol mesylate 40mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MitoQ Compound
Intervention Description
Mitoquinol mesylate
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Vanguard phase - change in myocardial PCr:ATP
Description
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
Time Frame
3 months
Title
Vanguard phase - change in circulating markers of oxidative stress
Description
The first 34 patients will enter a 3 months Vanguard phase. Change in circulating oxLDL and F2isoprostanes will be measured in plasma samples
Time Frame
3 months
Title
Primary outcome - change in LVESVi
Description
Change in LVESVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Vanguard phase - change in skeletal muscle PCr recovery
Description
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
Time Frame
3 months
Title
Follow-on phase - change in LVEF
Description
Change in LVEF (%) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time Frame
12 months
Title
Follow-on phase - change in LVEDVi
Description
Change in LVEDVi (ml/m2) between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time Frame
12 months
Title
Follow-on phase - change in GLS
Description
Change in GLS between baseline and follow-up amongst all 106 patients measured using cardiovascular magnetic resonance
Time Frame
12 months
Title
Follow-on phase - change in NT-pro-BNP
Description
Change in plasma concentrations of NT-pro-BNP (ng/L) between baseline and follow-up amongst all 106 patients
Time Frame
12 months
Title
Follow-on phase - change in renal function
Description
Change in creatinine and eGFR between baseline and follow-up amongst all 106 patients
Time Frame
12 months
Title
Follow-on phase - change in symptom burden
Description
Change in symptom score between baseline and follow-up amongst all 106 patients
Time Frame
12 months
Title
Follow-on phase - change in exercise capacity
Description
Change in 6 minute walk test distance between baseline and follow-up amongst all 106 patients
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria idiopathic or familial DCM LVEF ≤45% on 2 imaging studies of any modality ≥3 months apart (may include CMR scan at baseline visit) on guideline therapy for ≥3 months as determined by usual clinicians sinus rhythm on 12-lead electrocardiogram 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 current persistent atrial fibrillation contraindication to CMR estimated glomerular filtration rate (eGFR) <30mls/min current or planned pregnancy or current breast-feeding clear environmental trigger such as excess alcohol intake, cardiotoxic chemotherapy or peripartum presentation fibrosis burden >25% on CMR current cancer (other than non-melanoma skin cancers) current use of CoQ10 current participation in another randomised controlled trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsay Smith
Phone
02073528121
Email
mitoDCM@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Halliday, MBChB PhD
Organizational Affiliation
Imperial College London and Royal Brompton Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Smith
Email
mitoDCM@imperial.ac.uk

12. IPD Sharing Statement

Learn more about this trial

Examining the Effects of Mitochondrial Oxidative Stress in DCM

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