Pulmonary Hypertension
Conditions
Keywords
Sildenafil, Pediatrics
Brief summary
The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.
Detailed description
There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.
Interventions
PROCEDUREObtain blood specimens
Obtain blood samples at multiple timepoints.
Sponsors
Children's Hospital of Philadelphia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Days to No maximum
Healthy volunteers
No
Inclusion criteria
* Receive enteral sildenafil as standard of care * \> 28 days to \>18 years of age * Informed consent/assent
Exclusion criteria
* Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension | predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose |
Secondary
| Measure | Time frame |
|---|---|
| To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension. | Multiple time points throughout the study |
Countries
United States
Outcome results
None listed