Coenzyme Q-10 and Pulmonary Arterial Hypertension

Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension

The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the treatment of pulmonary hypertension.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Dietary supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects; Dietary supplement: Coenzyme Q-10 in Normal Control subjects

Detailed Description

Abnormalities in the blood vessels in the lung are the hallmark of pulmonary hypertension. Links between increased free radical production, mitochondrial dysfunction and pulmonary hypertension have been studied but are poorly understood. The mitochondria of cells is the location where cellular energy is created and free radicals are atoms or groups of atoms with an odd (unpaired) number of electrons and can be formed when oxygen interacts with certain molecules. Once formed these reactive radicals can start a chain reaction, like dominoes. Their chief danger comes from the damage they can do when they react with important cellular components. Cells may function poorly or die if this occurs. The body produces free radicals in the normal course of energy production and in pulmonary hypertension, free radical production is found to be increased. To prevent free radical damage the body has a defense system of antioxidants. Coenzyme Q-10 is an antioxidant and it helps to protect cells from damage caused by the body's own free radicals. By providing oral supplementation of coenzyme Q-10, free radical levels will be decreased and cellular functioning in the pulmonary blood vessels may improve and even return to near normal functioning.

The purpose of this study is to evaluate the effects of coenzyme Q-10, an antioxidant, in the treatment of pulmonary hypertension. We will assess coenzyme Q-10 supplementation in the treatment of pulmonary hypertension by clinical measurements and blood levels of certain cellular components. We would like to assess the effects of coenzyme Q-10 on the pulmonary vessels by measuring the lung diffusing capacity (a breathing test) and exhaled Nitric Oxide (NO) (a substance in the body that relaxes or dilates blood vessels). We will also measure endothelial progenitor cells (cells from the bone marrow) from a blood sample; these cells are markers of measure of blood vessel formation and repair. We will also measure the activity of superoxide dismutase (a protein in cells that executes the breakdown of a free radical into oxygen and hydrogen peroxide) in the blood. In addition, we will measure levels of coenzyme Q-10 in the blood. Other markers of disease response to therapy will be done including physical exam, BNP level (a blood marker that correlates with heart function), 6-minute walk and echocardiography (ultrasound of the heart). A total of 60ml (5 tablespoons) of blood will be drawn at each visit.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and Females age equal to or greater than 18 not to exceed 65.
• Patients with PAH Class 1 (Venice 2003)
• PAH medications must not have changed for the last two months.
• Women of child-bearing age must use a double-barrier local contraception until completion of study.
• Subjects must demonstrate understanding of study and sign informed consent and have a reliable method of communication for contact and the ability to comply with the study requirements.

Exclusion Criteria:

• Participation in any other studies at the time of enrollment
• History of any significant illness within four weeks of starting Coenzyme Q-10
• Hepatic insufficiency (transaminase levels >4 fold the upper limit of normal or bilirubin >2 fold the upper limit of normal).
• Renal insufficiency (creatinine >2)
• Pregnancy,breast-feeding or lack of safe contraception.
• Acute heart failure
• Known allergy to the study drug or drugs similar to the study drug
• History of drug or alcohol abuse within last 12 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coenzyme Q 10 and Pulmonary Hypertension; PAH subjects to take Co-Q daily for three months	Dietary supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects; Take 100mg Co-Q for three times daily; Other Names: Coenzyme Q: Nutritional Supplement
Experimental: Coenzyme Q 10 and Normal Controls; Normal controls to take Co-Q daily for three months	Dietary supplement: Coenzyme Q-10 in Normal Control subjects; Take 100mg Co-Q for three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular End Diastolic Volume	Amount of blood in ventricle at end of diastole	before and after three months of CoQ
Right Ventricular Outflow	Velocity time interval	before and after three months of CoQ
Right Ventricle Myocardial Performance	Tei Index=(IRT+ICT)/ET, where IRT is isovolumic	before and after three months of CoQ
Tricuspid Regurgitation Grade	Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)	before and after three months of CoQ
Right Atrial Pressure		before and after three months of CoQ

Secondary Outcome Measures

Outcome Measure	Time Frame
Red Blood Cells	before and after three months of CoQ
Hemoglobin	before and after three months of CoQ
Hematocrit	before and after three months of CoQ
Mean Corpuscular Hemoglobin	before and after three months of CoQ
Red Blood Cell Distribution Width	before and after three months of CoQ

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Jackie Sharp, CNP, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: March 19, 2010
• First Submitted That Met QC Criteria: June 21, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 20, 2015
• Last Update Submitted That Met QC Criteria: March 19, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; Coenzyme Q-10; Pulmonary Arterial Hypertension Class I (Venice 2003)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10; Ubiquinone
• Other Study ID Numbers: 08-497