Fontan Procedure
Conditions
Brief summary
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
Interventions
DRUGAspirin
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who have Fontan repair of single ventricle
Exclusion criteria
Persons with the following history, conditions, or behavior will be excluded * Active protein losing enteropathy within the past three years * Congestive heart failure * Active arrhythmias * Taking Coumadin (Warfarin) * Bleeding disorder * Known esophageal varicies * Consuming more than 10 alcoholic drinks per week. * Pregnant * Planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Cholesterol | 8 weeks | Change will be measured from baseline to retest after 8 weeks of treatment |
| Change in HDL (High-Density Lipoprotein)-Cholesterol | 8 weeks | Change will be measured from baseline to retest after 8 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Sensitivity CRP(C-Reactive Protein) | 8 weeks | Change will be measured from baseline to retest after 8 weeks of treatment |
| Quality of Life | 8 weeks | The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention: Aspirin 650 mg. Twice a day for 8 weeks
Aspirin | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Intervention: Aspirin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| HDL Cholesterol | 47.6 mg/dL STANDARD_DEVIATION 15.1 |
| High Sensitivity C-Reactive Protein | 0.24 mg/dL STANDARD_DEVIATION 0.1 |
| Quality of Life | 82.4 units on a scale STANDARD_DEVIATION 7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
| Total Cholesterol | 138.6 mg/dL STANDARD_DEVIATION 16.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Change in HDL (High-Density Lipoprotein)-Cholesterol
Change will be measured from baseline to retest after 8 weeks of treatment
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Aspirin | Change in HDL (High-Density Lipoprotein)-Cholesterol | 0.4 mg/dL | Standard Deviation 17.3 |
p-value: 0.67t-test, 2 sided
Primary
Change in Total Cholesterol
Change will be measured from baseline to retest after 8 weeks of treatment
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Aspirin | Change in Total Cholesterol | -0.6 mg/dL | Standard Deviation 15.5 |
p-value: 0.96t-test, 2 sided
Secondary
High Sensitivity CRP(C-Reactive Protein)
Change will be measured from baseline to retest after 8 weeks of treatment
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Aspirin | High Sensitivity CRP(C-Reactive Protein) | 0.06 mg/dL | Standard Deviation 0.09 |
p-value: 0.18t-test, 2 sided
Secondary
Quality of Life
The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention: Aspirin | Quality of Life | 86.5 units on a scale | Standard Deviation 4.1 |
p-value: 0.25t-test, 2 sided