Clinical trial NCT01148836: Coenzyme Q-10 and Pulmonary Arterial Hypertension
Official title: Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Coenzyme Q-10
Pulmonary Arterial Hypertension
Pulmonary Arterial Hypertension Class I (Venice 2003)
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Left Ventricular End Diastolic Volume
timeFrame: before and after three months of CoQ
measure: Right Ventricular Outflow
timeFrame: before and after three months of CoQ
measure: Right Ventricle Myocardial Performance
timeFrame: before and after three months of CoQ
measure: Tricuspid Regurgitation Grade
timeFrame: before and after three months of CoQ
measure: Right Atrial Pressure
timeFrame: before and after three months of CoQ
Secondary outcomes:
measure: Red Blood Cells
timeFrame: before and after three months of CoQ
measure: Hemoglobin
timeFrame: before and after three months of CoQ
measure: Hematocrit
timeFrame: before and after three months of CoQ
measure: Mean Corpuscular Hemoglobin
timeFrame: before and after three months of CoQ
measure: Red Blood Cell Distribution Width
timeFrame: before and after three months of CoQ
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jackie Sharp, CNP
role: PRINCIPAL_INVESTIGATOR
References: