Side Effects of Pulmonary Hypertension Medications

Stanford University

Status: Completed

Conditions: Pulmonary Hypertension

Study type: Observational

Funder types: Other

Identifiers

NCT01571713

PHSE22242

Details and patient eligibility

About

The study seeks to analyze the patient reported effects of pulmonary hypertension medications and compare these with the side effects described on the package inserts. Side effects for these PH medications have been described in the adult population, but have never been described in the pediatric population. This information can better improve patient care and be used to characterize the side effects resultant from these medications.

Full description

As part of standard of care, patients are routinely asked about any symptoms they might be experiencing. This study seeks to quantify these symptoms for research purposes. Participants will be identified through those who attend the pediatric pulmonary hypertension clinic at LPCH. Only children who are currently on one of seven PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris) will be approached. Patients who consent to be in the study will answer a brief series of questions pertaining to the presence and duration of their symptoms. These will be correlated to a list of side effects taken from Lexicomp (a medication database).

Enrollment: 250 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pulmonary hypertension
• currently taking at least one of the following PH medications (Bosentan, Epoprostenol, Letairis, Sildenafil, Tadalafil, Treprostinil, Ventaris)

Exclusion criteria

• >18 years

Trial design

250 participants in 1 patient group

Study

Description:

Pediatric patients with pulmonary hypertension