Coenzyme Q-10 and Pulmonary Arterial Hypertension

NCT01148836 | Completed Results

• 1 other identifier: 08-497
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Arterial Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Left Ventricular End Diastolic Volume

  Amount of blood in ventricle at end of diastole

  before and after three months of CoQ

• Right Ventricular Outflow

  Velocity time interval

  before and after three months of CoQ

• Right Ventricle Myocardial Performance

  Tei Index=(IRT+ICT)/ET, where IRT is isovolumic

  before and after three months of CoQ

• Tricuspid Regurgitation Grade

  Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)

  before and after three months of CoQ

• Right Atrial Pressure

  before and after three months of CoQ

Secondary Outcomes (5)

• 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

Study Arms (2)

Coenzyme Q 10 and Pulmonary Hypertension

EXPERIMENTAL

PAH subjects to take Co-Q daily for three months

Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects

Coenzyme Q 10 and Normal Controls

EXPERIMENTAL

Normal controls to take Co-Q daily for three months

Dietary Supplement: Coenzyme Q-10 in Normal Control subjects

Interventions

Coenzyme Q-10 in Pulmonary Hypertension subjects DIETARY_SUPPLEMENT

Take 100mg Co-Q for three times daily

Also known as: Coenzyme Q: Nutritional Supplement

Coenzyme Q 10 and Pulmonary Hypertension

Coenzyme Q-10 in Normal Control subjects DIETARY_SUPPLEMENT

Take 100mg Co-Q for three times daily

Coenzyme Q 10 and Normal Controls

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Ubiquinone

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzoquinones; Quinones; Organic Chemicals; Coenzymes; Enzymes and Coenzymes

Limitations and Caveats

Length of the trial and number of subjects enrolled were both study limitations.

Results Point of Contact

• Title: Jacqueline Sharp, CNP
• Organization: Cleveland Clinic

pylej@ccf.org

216-636-0000

Study Officials

• Jackie Sharp, CNP

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: June 22, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 20, 2015
• Results First Posted: March 20, 2015

Record last verified: 2015-03

Locations

US (1)