Trial Outcomes & Findings for Coenzyme Q-10 and Pulmonary Arterial Hypertension (NCT NCT01148836)
NCT ID: NCT01148836
Last Updated: 2015-03-20
Results Overview
Amount of blood in ventricle at end of diastole
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
before and after three months of CoQ
Results posted on
2015-03-20
Participant Flow
Participant milestones
| Measure |
Healthy Controls
|
Pulmonary Hypertension Subjects (Disease)
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coenzyme Q-10 and Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Healthy Controls Subjects
n=7 Participants
|
Pulmonary Hypertension Subjects
n=8 Participants
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 5 • n=5 Participants
|
41 years
STANDARD_DEVIATION 3 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: before and after three months of CoQPopulation: Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q
Amount of blood in ventricle at end of diastole
Outcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Left Ventricular End Diastolic Volume
Before Co-Q
|
81 ml
Standard Deviation 10
|
—
|
|
Left Ventricular End Diastolic Volume
After Co-Q
|
70 ml
Standard Deviation 8
|
—
|
PRIMARY outcome
Timeframe: before and after three months of CoQPopulation: Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q
Velocity time interval
Outcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Right Ventricular Outflow
Before Co-Q
|
11.3 cm
Standard Deviation 1.4
|
—
|
|
Right Ventricular Outflow
After Co-Q
|
13.5 cm
Standard Deviation 1.6
|
—
|
PRIMARY outcome
Timeframe: before and after three months of CoQPopulation: Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q
Tei Index=(IRT+ICT)/ET, where IRT is isovolumic
Outcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Right Ventricle Myocardial Performance
Before Co-Q
|
0.9 ratio
Standard Deviation 0.2
|
—
|
|
Right Ventricle Myocardial Performance
After Co-Q
|
0.7 ratio
Standard Deviation 0.1
|
—
|
PRIMARY outcome
Timeframe: before and after three months of CoQPopulation: Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q
Tricuspid Regurgitation Grade ranges from 1 (normal) to 4 (severe regurgitation)
Outcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Tricuspid Regurgitation Grade
Before Co-Q
|
1.4 units on a scale
Standard Deviation 0.3
|
—
|
|
Tricuspid Regurgitation Grade
After Co-Q
|
1.2 units on a scale
Standard Deviation 0.3
|
—
|
PRIMARY outcome
Timeframe: before and after three months of CoQPopulation: Due to financial constraints only PAH subjects had echocardiograms performed before and after Co-Q
Outcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Right Atrial Pressure
Before Co-Q
|
10 mmHg
Standard Deviation 2
|
—
|
|
Right Atrial Pressure
After Co-Q
|
8 mmHg
Standard Deviation 1
|
—
|
SECONDARY outcome
Timeframe: before and after three months of CoQOutcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
n=7 Participants
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Red Blood Cells
Before Co-Q
|
5.2 10^6 cells/µl
Standard Deviation 0.2
|
4.5 10^6 cells/µl
Standard Deviation 0.1
|
|
Red Blood Cells
After Co-Q
|
5.2 10^6 cells/µl
Standard Deviation 0.2
|
4.3 10^6 cells/µl
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: before and after three months of CoQOutcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
n=7 Participants
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Hemoglobin
Before Co-Q
|
14.1 g/dl
Standard Deviation 0.9
|
13.3 g/dl
Standard Deviation 0.4
|
|
Hemoglobin
After Co-Q
|
14.6 g/dl
Standard Deviation 0.8
|
12.9 g/dl
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: before and after three months of CoQOutcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
n=7 Participants
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Hematocrit
Before Co-Q
|
43.0 % of red blood cell
Standard Deviation 2.1
|
39.9 % of red blood cell
Standard Deviation 1.0
|
|
Hematocrit
After Co-Q
|
43.8 % of red blood cell
Standard Deviation 1.8
|
38.6 % of red blood cell
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: before and after three months of CoQOutcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
n=7 Participants
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Mean Corpuscular Hemoglobin
Before Co-Q
|
26.8 pg
Standard Deviation 1.1
|
29.9 pg
Standard Deviation 0.8
|
|
Mean Corpuscular Hemoglobin
After Co-Q
|
27.8 pg
Standard Deviation 1.0
|
29.9 pg
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: before and after three months of CoQOutcome measures
| Measure |
Pulmonary Hypertension Subjects
n=8 Participants
Pulmonary Hypertension subjects taking Co-Q for three months
|
Normal Controls
n=7 Participants
Normal controls taking Co-Q for three months
|
|---|---|---|
|
Red Blood Cell Distribution Width
Before Co-Q
|
15.0 percentage of sizes of red blood cells
Standard Deviation 0.6
|
12.9 percentage of sizes of red blood cells
Standard Deviation 0.2
|
|
Red Blood Cell Distribution Width
After Co-Q
|
14.5 percentage of sizes of red blood cells
Standard Deviation 0.5
|
12.9 percentage of sizes of red blood cells
Standard Deviation 0.4
|
Adverse Events
Coenzyme Q and Pulmonary Hypertension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Coenzyme Q and Healthy Controls
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coenzyme Q and Pulmonary Hypertension
n=10 participants at risk
Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
|
Coenzyme Q and Healthy Controls
n=8 participants at risk
Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • The adverse event data was collected over each participants treatment period, up to three months.
|
12.5%
1/8 • Number of events 1 • The adverse event data was collected over each participants treatment period, up to three months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • The adverse event data was collected over each participants treatment period, up to three months.
|
0.00%
0/8 • The adverse event data was collected over each participants treatment period, up to three months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place