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| Name | Class |
|---|---|
| Children's Miracle Network | OTHER |
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The study will test the hypothesis that a single dose of sildenafil can increase the exercise capacity of pediatric patients with a Fontan Circulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil crossover to placebo | Active Comparator | Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2, placebo drug administered before the exercises. |
|
| Placebo crossover to sidenafil | Placebo Comparator | Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with treatment 2 Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will be randomized to receive Sildenafil first and then crossed over to receive the opposite intervention, placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) | A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test | baseline to 1 hour |
| The Change in Exercise Capacity Measured Via Exercise Time | A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test | baseline to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Exercise Capacity Measured Via Maximum Heart Rate | A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test | Baseline to 1 Hour |
| The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devyani Chowdhury, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
One subject withdrew consent before being randomized and subsequent medication administered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil Crossover to Placebo | Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises. |
| FG001 | Placebo Crossover to Sidenafil | Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil Crossover to Placebo | Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises. |
| BG001 | Placebo Crossover to Sidenafil |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Change in Exercise Capacity Measured Via Maximum Oxygen Consumed During Exercise (VO2) | A change in exercise capacity measured via maximum oxygen consumed during exercise (VO2). The measurement will be obtained from the Exercise Stress Test | Posted | Mean | Standard Error | ml/min/kg | baseline to 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil Crossed Over to Placebo | Sildenafil dosage (0.5mg/kg (max 20mg)) administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the placebo drug administered before the exercises. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushed skin | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Compliance Specialist | Milton S. Hershey Medical Center | 7175310003 | 287544 | clinicaltrials.gov@pennstatehealth.psu.edu |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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|
| Placebo | Drug | Patient will receive a look-alike placebo. Enrolled patients will be randomized to receive Placebo first and then crossed over to receive the opposite intervention, Sildenafil. |
|
|
| Sildenafil 2 | Drug | oral suspension, 0.5mg/kg, taken once prior to exercise stress test. Enrolled patients will receive Sildenafil, the crossed over intervention from their initial intervention (Placebo). |
|
|
| Placebo 2 | Drug | Patient will receive a look-alike placebo. Enrolled patients will receive Placebo, the crossed over intervention from their initial intervention (Sildenafil). |
|
|
A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test |
| Baseline to 1 Hour |
| The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). | A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute | Baseline to 1 hour |
Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | The Change in Exercise Capacity Measured Via Exercise Time | A change in exercise capacity measured via exercise time (in minutes). The measurement will be obtained from the Exercise Stress Test | Posted | Mean | Standard Error | minutes | baseline to 1 hour |
|
|
|
| Secondary | The Change in Exercise Capacity Measured Via Maximum Heart Rate | A change in exercise capacity measured via maximum heart rate (in beats per minute). The measurement will be obtained from the Exercise Stress Test | Posted | Mean | Standard Error | beats per minute | Baseline to 1 Hour |
|
|
|
| Secondary | The Change in Exercise Capacity Measured Via Minimum Oxygen Saturation Levels. | A change in exercise capacity measured via minimum oxygen saturation (%). The measurement will be obtained from the Exercise Stress Test | Posted | Mean | Standard Error | Percentage of oxygen saturation | Baseline to 1 Hour |
|
|
|
| Secondary | The Change in Exercise Capacity Measured Via Metabolic Equivalents of Task (METs). | A change in exercise capacity measured via metabolic equivalents of task (METs). The measurement will be obtained from the Exercise Stress Test. One MET is defined as 3.5 mL 02 uptake/kg per minute | Posted | Mean | Standard Error | Mets | Baseline to 1 hour |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Placebo Crossed Over to Sildenafil | Patient will receive a look-alike placebo administered at the time of enrollment followed by a battery of exercise tests. After a washout period, the process will be repeated with the Sildenafil dosage will be 0.5mg/kg (max 20mg) administered before the exercises. | 0 | 15 | 0 | 15 |
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| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |