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Side Effects of Pulmonary Hypertension Medications

This study is currently recruiting participants.
Verified October 2016 by Jeffrey A. Feinstein, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01571713
First Posted: April 5, 2012
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeffrey A. Feinstein, Stanford University
  Purpose
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.

Condition
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient Reported Side Effects of Pulmonary Hypertension (PH) Medications

Resource links provided by NLM:


Further study details as provided by Jeffrey A. Feinstein, Stanford University:

Primary Outcome Measures:
  • Patients Experience Side Effects [ Time Frame: Open ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study
Pediatric patients with pulmonary hypertension

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with pulmonary hypertension seen in the pulmonary hypertension clinic at Stanford Lucile Packard Children's Hospital
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571713


Contacts
Contact: Jeffrey Feinstein, MD, MPH 650 723 7913 jeff.feinstein@stanford.edu

Locations
United States, California
Lucile Packard Children's Hospital at Stanford Recruiting
Stanford, California, United States, 94305
Contact: Jeffrey Feinstein, MD, MPH    650-723-7913    jeff.feinstein@stanford.edu   
Principal Investigator: Jeffrey Feinstein, MD, MPH         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jeffrey Feinstein, MD, MPH Stanford University
  More Information

Responsible Party: Jeffrey A. Feinstein, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01571713     History of Changes
Other Study ID Numbers: PHSE22242
First Submitted: April 3, 2012
First Posted: April 5, 2012
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases