Side Effects of Pulmonary Hypertension Medications

Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01571713

Enrollment

250

Registered

2012-04-05

Start date

2011-08-31

Completion date

2020-12-31

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Brief summary

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.

Detailed 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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Patients Experience Side Effects	Open

Countries

United States

Outcome results