N/A
Completed N=18
Coenzyme Q-10 and Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov NCT01148836 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Left Ventricular End Diastolic Volume — 81; 70 ml
Summary
The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the treatment of pulmonary hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular End Diastolic Volume |
81; 70 | — |
| PRIMARY Right Ventricular Outflow |
11.3; 13.5 | — |
| PRIMARY Right Ventricle Myocardial Performance |
0.9; 0.7 | — |
| PRIMARY Tricuspid Regurgitation Grade |
1.4; 1.2 | — |
| PRIMARY Right Atrial Pressure |
10; 8 | — |
| SECONDARY Red Blood Cells |
5.2; 4.5; 5.2; 4.3 | — |
| SECONDARY Hemoglobin |
14.1; 13.3; 14.6; 12.9 | — |
| SECONDARY Hematocrit |
43.0; 39.9; 43.8; 38.6 | — |
| SECONDARY Mean Corpuscular Hemoglobin |
26.8; 29.9; 27.8; 29.9 | — |
| SECONDARY Red Blood Cell Distribution Width |
15.0; 12.9; 14.5; 12.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT01148836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.