Pulmonary Arterial HypertensionNCT01148836
Coenzyme Q-10 and Pulmonary Arterial Hypertension
A study testing Coenzyme Q-10 in Pulmonary Hypertension subjects in people with Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the treatment of pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Coenzyme Q-10 in Pulmonary Hypertension subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension
The purpose of this study is to evaluate the effects of Coenzyme Q-10, an antioxidant, in the treatment of pulmonary hypertension.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Coenzyme Q-10 in Pulmonary Hypertension subjects, Coenzyme Q-10 in Normal Control subjects
- Keywords
- Coenzyme Q-10, Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Class I (Venice 2003)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q-10 in Pulmonary Hypertension subjectsDietary supplement
Also called Coenzyme Q: Nutritional Supplement
Take 100mg Co-Q for three times daily
Coenzyme Q-10 in Normal Control subjectsDietary supplement
Take 100mg Co-Q for three times daily
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q 10 and Pulmonary Hypertension | Experimental | PAH subjects to take Co-Q daily for three months Receives: 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 Receives: Dietary Supplement: Coenzyme Q-10 in Normal Control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular End Diastolic Volume
Amount of blood in ventricle at end of diastole
Measured: before and after three months of CoQ
Right Ventricular Outflow
Velocity time interval
Measured: before and after three months of CoQ
Right Ventricle Myocardial Performance
Tei Index=(IRT+ICT)/ET, where IRT is isovolumic
Measured: before and after three months of CoQ
Tricuspid Regurgitation Grade
Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)
Measured: before and after three months of CoQ
Right Atrial Pressure
Measured: before and after three months of CoQ
Secondary outcomes (5)
Red Blood Cells
Measured: before and after three months of CoQ
Hemoglobin
Measured: before and after three months of CoQ
Hematocrit
Measured: before and after three months of CoQ
Mean Corpuscular Hemoglobin
Measured: before and after three months of CoQ
Red Blood Cell Distribution Width
Measured: before and after three months of CoQ
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Sharp, The Cleveland Clinic
- Investigators
- Jackie Sharp, CNP, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148836
- Sponsor's protocol ID
- 08-497
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2010
- Last updated
- 20 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01148836
- Acronym / sponsor ID
- 08-497
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Coenzyme Q-10, Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension Class I (Venice 2003)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q 10 and Pulmonary Hypertension | Experimental | Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjectsPAH subjects to take Co-Q daily for three months |
| Coenzyme Q 10 and Normal Controls | Experimental | Dietary Supplement: Coenzyme Q-10 in Normal Control subjectsNormal controls to take Co-Q daily for three months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q-10 in Pulmonary Hypertension subjectsAlso: Coenzyme Q: Nutritional SupplementTake 100mg Co-Q for three times daily | Dietary supplement | Coenzyme Q 10 and Pulmonary Hypertension |
| Coenzyme Q-10 in Normal Control subjectsTake 100mg Co-Q for three times daily | Dietary supplement | Coenzyme Q 10 and Normal Controls |
Primary outcome
Left Ventricular End Diastolic Volume
Time frame: before and after three months of CoQ
Amount of blood in ventricle at end of diastole
Right Ventricular Outflow
Time frame: before and after three months of CoQ
Velocity time interval
Right Ventricle Myocardial Performance
Time frame: before and after three months of CoQ
Tei Index=(IRT+ICT)/ET, where IRT is isovolumic
Tricuspid Regurgitation Grade
Time frame: before and after three months of CoQ
Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)
Right Atrial Pressure
Time frame: before and after three months of CoQ
5 secondary outcomes
Red Blood Cells
Time frame: before and after three months of CoQ
Hemoglobin
Time frame: before and after three months of CoQ
Hematocrit
Time frame: before and after three months of CoQ
Mean Corpuscular Hemoglobin
Time frame: before and after three months of CoQ
Red Blood Cell Distribution Width
Time frame: before and after three months of CoQ
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
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Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Sharp, CNP principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q-10 in Pulmonary Hypertension subjects in people with Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular End Diastolic Volume (time frame: before and after three months of CoQ). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.