Clinical Trial: Coenzyme Q-10 and Pulmonary Arterial Hypertension

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension

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

Detailed Summary:

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 me
Sponsor: The Cleveland Clinic

Current Primary Outcome:

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


Original Primary Outcome: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI [ Time Frame: Within 30 (plus or minus 3 days) after surgery ]

Measures of superoxide dismutase (SOD) activity, exhaled nitric oxide (NO), and its circulating products, and circulating progenitor cells in relation to clinical outcomes.


Current Secondary Outcome:

  • Red Blood Cells [ Time Frame: before and after three months of CoQ ]
  • Hemoglobin [ Time Frame: before and after three months of CoQ ]
  • Hematocrit [ Time Frame: before and after three months of CoQ ]
  • Mean Corpuscular Hemoglobin [ Time Frame: before and after three months of CoQ ]
  • Red Blood Cell Distribution Width [ Time Frame: before and after three months of CoQ ]


Original Secondary Outcome:

Information By: The Cleveland Clinic

Dates:
Date Received: March 19, 2010
Date Started: January 2010
Date Completion:
Last Updated: March 19, 2015
Last Verified: March 2015