Clinical Trials
Investigator-Initiated Trials
Department |
Study |
Principal Investigator |
Contact |
| Cardiology | PH Biobank
WHO Group I, mean PAP > 25 mmHg, PCWP < 18 mmHg, Patients can be both incident (newly diagnosed) and prevalent (actively on PH therapy). Also including patients who participated in the REVEAL study. Enrollment Goal: 82/250
|
Marc Simon, MD | Traci McGaha, RN
692-4828 |
| Cardiology | Inhaled Nitrite
A single-center, open label phase II study to evaluate the effect of inhaled nitrite delivered in a dose escalation manner (45mg & 90mg) on the change in pulmonary vascular resistance (PVR) in subjects with pulmonary arterial hypertension undergoing right heart catheterization. Enrollment Goal: WHO Group I 20/20 (closed); WHO Group II 11/20; WHO Group III 6/10
|
Marc Simon, MD | Pamela White, RN, BSN, CCRC
412-624-3147 Pager 9002 |
| PACCM | PH and HF Research Registry and Sample Repository
Blood work and QOL questionnaires. Enrollment Goal: 2-5 per week; no current cap
|
Marc Simon, MD | Annie Watson, MPH
412-647-4964 |
| PACCM | Pulmonary Hypertension and the Microbiome (PHAM)
Any pulmonary hypertension patient who is scheduled for a RHC is eligible. Enrollment Goal: 100
|
Alison Morris, MD, MS | Nicolas Leo
412-726-5472 |
| Cardiology | Genetic and Environment in PH
Enrollment Goal: 1/20
|
Stephen Chan, MD, PhD | Jessica Pisarcik, RN
412-647-4463 |
| Cardiology | RHC Retrospective Data Collection
Database build of all patients having right heart catheterization linked to EMR Enrollment Goal: 11,000 and ongoing
|
Marc Simon, MD | Leslie Mitrik
|
Industry-Sponsored Trials
Department |
Study |
Principal Investigator |
Contact |
| Cardiology | Triton Trial
Initiating triple therapy with PAH (SELEXIPAG) Enrollment Goal: 2
|
Michael Mathier, MD | Kristin Shoemaker, RN
412-692-2769 |
| Cardiology | LIBERTY
Ubenimex for Pulmonary Arterial Hypertension. Leukotriene inhibitor, used in Japan for acute nonlymphocytic leukemia at dose of 30 mg/day. This is first trial in PAH, at dose of 150mg TID. For 24 weeks + extension. Targets increased macrophages/leukotriene secretion in PA causing endothelial cell apoptosis and vascular smooth muscle cell proliferation. Enrollment Goal: 2
|
Marc Simon, MD | Kristin Shoemaker, RN
412-692-2769 |
| Cardiology | Arena (Ralinepag)
An Open-label Pilot Study followed by a Double-blind, Randomized, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with PAH. Inclusion: WHO group 1, ages 18-75 years, drug naïve OR may be on ERA and/or PDE-5i. Functional Class II-IV Enrollment Goal: 2
|
Marc Simon, MD | Jessica Pisarcik, RN
412-647-4463 |
| Cardiology | The BEAT Trial
A multicenter, double-blind, randomized, placebo-controlled, Phase 3 study to assess the efficacy and safety of oral BPS-314d-MR added-on to treprostinil, inhaled (Tyvaso®) in subjects with pulmonary arterial hypertension. Inclusion: ages 18-80 years old, WHO class I, Functional Class III-IV, are on or going to be started on Tyvaso. Enrollment Goal: 8/5 (exceeded and ongoing)
|
Michael Mathier, MD | Kristin Shoemaker, RN
412-692-2769 |
| Cardiology | TDE 310/311 (FREEDOM)
A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with PAH Receiving UT-15C in Combination with a PDE5-I or ERA Compared with a PDE5-I or ERA Alone. Inclusion: single background oral therapy for greater than 30 days but less than 1 year from initial therapy, ages 18-75 years. 310: placebo study and 311: open label extension. Enrollment Goal: 1/3-4
|
Michael Mathier, MD | Kristin Shoemaker, RN
412-692-2769 |
| Cardiology | REPAIR Trial
A Prospective, Multicenter, Single-arm, Open-Label, Phase IV study of the Effects of Macitentan on Right Ventricular Remolding in Pulmonary Arterial Hypertension assess by Cardiac Magnetic Resonance Imaging. Enrollment Goal: 1/4
|
Marc Simon, MD | Kristin Shoemaker, RN
412-692-2769 |
| Cardiology | SELEXIPAG SWITCH
Switch from inhaled treprostinil (Tyvaso) to SELEXIPAG Enrollment Goal: 2
|
Michael Mathier, MD | Kristin Shoemaker, RN
412-692-2769 |
| PACCM | Macitentan Registry – OPUS
Post-market registry of macitentan in PAH. Enrollment: 1
|
Michael Risbano, MD | Sarah Rapport
412-488-5003 |
| Rheumatology, Scleroderma Research Center | ASC01
A randomized, double-blind, placebo-controlled, phase II multicenter trial of a monoclonal antibody to CD20 (Rituximab) for the treatment of systemic sclerosis-associated PAH. Enrollment Goal:
|
Robyn Domsic | Dana Ivanco
412-648-7040 |
| PACCM | PORTICO
A randomized, double-blind, placebo-controlled, prospective, multicenter parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension (PoPH). Enrollment Goal: 1/2
|
Belinda Rivera-Lebron, MD | Swati Gulati
412-692-2210 |