Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Chronic Obstructive Pulmonary Disease (COPD)

February 24, 2025 updated by: Virginia Commonwealth University

The Influence of Mitochondrial Derived Reactive Oxygen Species on Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Cardiovascular health is a critical problem in patients with chronic obstructive pulmonary disease (COPD). Existing literature suggests oxidative stress from the mitochondria c driving some of the poor health outcomes in COPD. MitoQ is a mitochondrial-targeted antioxidant that has shown promise in improving cardiovascular outcomes in similar populations. Thus the purpose of this study is to test if MitoQ can improve cardiovascular health in COPD.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, a mitochondria-specific antioxidant will be compared to a placebo. Participants will be assigned randomly to receive either the antioxidant or the placebo for 6 weeks. A comprehensive assessment of cardiovascular health will be conducted before and after the administration of the supplement.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically diagnosed of COPD
  • Global Initiative for obstructive lung disease (GOLD) Stages II to IV

Exclusion Criteria:

  • Forced Expiratory Volume in 1 second/ Functional Vital Capacity (FEV1/FVC) >0.7
  • Heart Disease
  • Diabetes
  • Vasoactive medications
  • Uncontrolled high blood pressure
  • Fluid in lungs
  • Sleep apnea
  • Raynaud's Phenomenon
  • Gangrene of the digits
  • History of coagulation
  • Pregnant women
  • Children

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MitoQ
Participants will take 1 pill each day for 6 weeks
Drug: MitoQ
MitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter.
Placebo Comparator: Placebo
Participants will take 1 pill each day for 6 weeks
Other: Placebo
A look-alike inactive substance, a "sugar pill"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vascular function
Time Frame: Baseline and 6 weeks
Flow-mediated dilation will be used to measure vasodilation in the brachial artery
Baseline and 6 weeks
Change in Skeletal Muscle Oxygenation
Time Frame: Baseline and 6 weeks
Near-infrared spectroscopy will be used to measure leg muscle oxygenation
Baseline and 6 weeks
Change in oxidative stress
Time Frame: Baseline and 6 weeks
Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in arterial stiffness
Time Frame: Baseline and 6 weeks
Pulse wave velocity will be used to measure arterial stiffness.
Baseline and 6 weeks
Change in microvascular function
Time Frame: Baseline and 6 weeks
Microvascular function will be assessed using laser dopler imaging
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Paula Rodriguez-Miguelez, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

October 28, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM20021976
  • 905812 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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