IRB Number:

06-002271

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This study is being done to better understand the medical management of patients with a new or existing diagnosis of PAH. Other objectives include describing the demographic and clinical characteristics of PAH patients as well as identifying medical practices associated with improved health outcomes. This study will collect information on approximately 3,000 patients with PAH at approximately 50 sites in the United States. Data will be collected on patients for at least five years, including past data, if applicable (data from medical records that were recorded prior to the start of the REVEAL Registry) and follow-up telephone and clinic visit data.

As this is an information-gathering study only, your physician will manage your care no differently than he/she would if you were not part of this registry program. You do not need to participate in the REVEAL Registry to receive treatment for your condition. Participating in the REVEAL Registry will not influence the usual care that you receive from your doctor. Specifically, the care you receive from your doctor while participating in the REVEAL Registry will be the same as the care you would receive if you were not participating in this research program.

Who is Eligible to Participate in the Study?

Men or women diagnosed with Pulmonary Arterial Hypertension (PAH) may be eligible to participate in this research study.

What is Involved With this Study?

All patients will be evaluated at a screening visit to determine eligibility and to confirm willingness to participate in the REVEAL Registry. This will occur at the time of your regular visit to the Pulmonary Hypertension Clinic. Upon signing of this consent form and HIPAA authorization form, a retrospective (past) medical history may be obtained by patient interview and by review of the medical record, if applicable, during the course of your regular visit. Thereafter, your medical data will be collected at your usually scheduled visits (often this occurs on approximately a quarterly basis, but no specially scheduled visits or calls will be necessary), or at any clinic or hospital visit or telephone discussions which occur during the course of your regular pulmonary hypertension care. The data collected from you will be stored in an electronic database. Data will be collected prospectively for at least 5 years. The type of data that will be collected during the REVEAL Registry may include:

• Demographics (age, race and gender);


• The time and symptoms of first diagnosis of PAH;


• Results of routinely conducted heart and breathing tests;


• Results of routinely conducted laboratory testing;


• Vital signs (blood pressure, heart rate, weight and height)


• Hospitalizations


• Medications related to PAH and changes in medications

How long will the Study run?

Participants will be enrolled in this research study for up to five years from the date of enrollment.

Who can I Contact for Additional Information on this Trial?

If you are interested in participating in this study or would like additional information, please contact Erika E. Elmer, BA, CCRP
at (904) 953-7581.

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 01/14/2009