Coenzyme Q-10 and Pulmonary Arterial Hypertension

Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148836

Enrollment

Registered

2010-06-22

Start date

2010-01-31

Completion date

2014-01-31

Last updated

2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Arterial Hypertension

Keywords

Coenzyme Q-10, Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Class I (Venice 2003)

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.

Interventions

DIETARY_SUPPLEMENTCoenzyme Q-10 in Pulmonary Hypertension subjects

Take 100mg Co-Q for three times daily

DIETARY_SUPPLEMENTCoenzyme Q-10 in Normal Control subjects

Take 100mg Co-Q for three times daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Healthy Controls Subjects	7
Pulmonary Hypertension Subjects	8
Total	15

Baseline characteristics

Characteristic	Pulmonary Hypertension Subjects	Healthy Controls Subjects	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	8 Participants	7 Participants	15 Participants
Age, Continuous	41 years STANDARD_DEVIATION 3	42 years STANDARD_DEVIATION 5	41.5 years STANDARD_DEVIATION 3
Region of Enrollment United States	8 participants	7 participants	15 participants
Sex: Female, Male Female	7 Participants	6 Participants	13 Participants
Sex: Female, Male Male	1 Participants	1 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1 / 10	1 / 8
serious Total, serious adverse events	0 / 10	0 / 8