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Coenzyme Q-10 and Pulmonary Arterial Hypertension

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ClinicalTrials.gov Identifier: NCT01148836
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Jacqueline Sharp, The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects Dietary Supplement: Coenzyme Q-10 in Normal Control subjects Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension
Study Start Date : January 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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U.S. FDA Resources

Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Left Ventricular End Diastolic Volume [ Time Frame: before and after three months of CoQ ]
    Amount of blood in ventricle at end of diastole

  2. Right Ventricular Outflow [ Time Frame: before and after three months of CoQ ]
    Velocity time interval

  3. Right Ventricle Myocardial Performance [ Time Frame: before and after three months of CoQ ]
    Tei Index=(IRT+ICT)/ET, where IRT is isovolumic

  4. Tricuspid Regurgitation Grade [ Time Frame: before and after three months of CoQ ]
    Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)

  5. Right Atrial Pressure [ Time Frame: before and after three months of CoQ ]

Secondary Outcome Measures :
  1. Red Blood Cells [ Time Frame: before and after three months of CoQ ]
  2. Hemoglobin [ Time Frame: before and after three months of CoQ ]
  3. Hematocrit [ Time Frame: before and after three months of CoQ ]
  4. Mean Corpuscular Hemoglobin [ Time Frame: before and after three months of CoQ ]
  5. Red Blood Cell Distribution Width [ Time Frame: before and after three months of CoQ ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01148836


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jackie Sharp, CNP The Cleveland Clinic
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jacqueline Sharp, Nurse Practitioner, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01148836     History of Changes
Other Study ID Numbers: 08-497
First Posted: June 22, 2010    Key Record Dates
Results First Posted: March 20, 2015
Last Update Posted: March 20, 2015
Last Verified: March 2015

Keywords provided by Jacqueline Sharp, The Cleveland Clinic:
Coenzyme Q-10
Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension Class I (Venice 2003)

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
 Coenzyme Q10
Ubiquinone
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs