Status:
COMPLETED
Coenzyme Q-10 and Pulmonary Arterial Hypertension
Lead Sponsor:
The Cleveland Clinic
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-55 years
Phase:
NA
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 be...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01148836
Start Date
January 1 2010
End Date
January 1 2014
Last Update
March 20 2015
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195