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SYMPHONY study


Trial Focus

Trial Focus

Heart & Circulation, Lungs & Respiratory

Objective

        
The primary goals of this study are to evaluate how well the PAH-SYMPACT instrument (survey) works to measure health and track changes in health in patients with Pulmonary Arterial Hypertension. (PAH).  The secondary goal is to assess the safety of macitentan in patients with PAH.  The study also hopes to find out how macitentan effects PAH symptoms as measured by the PAH-SYMPACT instrument in patients with PAH.

IRB Protocol #

13-1841

Trial Status

Accepting Participants

Contact

Deb McCollister RN at 720-848-6540 or deb.mccollister@ucdenver.edu

Location

University of Colorado HospitalUniversity of Colorado Hospital

Eligibility and Other Participant Information


Main Inclusion Criteria:
1) Age 18-80
2) Patients with Group 1 PAH (Idiopathic, heritable, drug/toxin-induced, associated with connective tissue disease, congenital heart disease, HIV infection)
3) mPAP >/= 25mm Hg, PVR >/= 240 dynes, PCWP or LVEDP </= 15mm Hg
4) Able to fluently speak and read English

Main Exclusion Criteria:
1) Moderate to severe obstructive/restrictive lung disease
2) Clinically relevant hepatic dysfunction and/or renal insufficiency
3) Treatment with endothelin receptor antagonists, IV or subcutaneous prostacyclins, or riociguat within 3 months of beginning the trial.
For more information, please contact the Pulmonary Hypertension Center at 720-848-6518