Skip to main content
Clinical Trials/NCT05605548
NCT05605548
Terminated
Early Phase 1

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

Virginia Commonwealth University1 site in 1 country4 target enrollmentFebruary 16, 2023

Overview

Phase
Early Phase 1
Intervention
MitoQ
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Virginia Commonwealth University
Enrollment
4
Locations
1
Primary Endpoint
Change in Skeletal Muscle Oxygenation
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
February 16, 2023
End Date
July 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Vasoactive medications
  • Uncontrolled high blood pressure
  • Fluid in lungs
  • Sleep apnea
  • Raynaud's Phenomenon
  • Gangrene of the digits
  • History of coagulation
  • Pregnant women

Arms & Interventions

MitoQ

Participants will take 1 pill each day for 6 weeks

Intervention: MitoQ

Placebo

Participants will take 1 pill each day for 6 weeks

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Skeletal Muscle Oxygenation

Time Frame: Baseline and 6 weeks

Near-infrared spectroscopy will be used to measure leg muscle oxygenation

Change in vascular function

Time Frame: Baseline and 6 weeks

Flow-mediated dilation will be used to measure vasodilation in the brachial artery

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

Secondary Outcomes

  • Change in arterial stiffness(Baseline and 6 weeks)
  • Change in microvascular function(Baseline and 6 weeks)

Study Sites (1)

Loading locations...

Similar Trials