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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605548
• Other study ID #: HM20021976
• Secondary ID: 905812
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 16, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Paula Rodriguez-Miguelez, PhD
• Phone: 804-396-4498
• Email: prodriguezmig[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MitoQ
MitoQ is a mitochondrial targeted antioxidant that can be obtained over-the-counter.

Other:
• Placebo
A look-alike inactive substance, a "sugar pill"

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular function	Flow-mediated dilation will be used to measure vasodilation in the brachial artery	Baseline and 6 weeks
Primary	Change in Skeletal Muscle Oxygenation	Near-infrared spectroscopy will be used to measure leg muscle oxygenation	Baseline and 6 weeks
Primary	Change in oxidative stress	Blood draws will be taken to measure oxidative stress markers in the blood through electron paramagnetic resonance	Baseline and 6 weeks
Secondary	Change in arterial stiffness	Pulse wave velocity will be used to measure arterial stiffness.	Baseline and 6 weeks
Secondary	Change in microvascular function	Microvascular function will be assessed using laser dopler imaging	Baseline and 6 weeks