Clinical Trials

Participating in clinical trials and observational studies helps to further the mission of medicine by testing new treatments and strategies on actual people. This could include trying a new drug against a placebo, making specific adjustments to diet, or comparing a new drug against its previous formula. Research like this is critical to what we do at University Medical Center, as our academic medical center pioneers research through our relationships with LSU Health New Orleans and Tulane University School of Medicine.

If you are interested in learning more about what takes place during a clinical study, click here.

Current & recent PH clinical research studies

New research is undertaken all the time. As our hospital teaches medical students and helps them to learn the fundamentals of advancing the field of medicine, we welcome any patients interested in being part of the path forward.

Some notable pulmonary hypertension studies include:

• PHAR: Pulmonary Hypertension Association Registry – The main objective of PHAR is to measure and improve quality of life in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary hypertension (CTEPH) by improving clinical care and developing best care practices.
• U.S. CTEPH Registry – The ultimate goal of the chronic thromboembolic pulmonary hypertension (CTEPH) registry is to improve CTEPH patients’ quality of life through better understanding of this disease and its best treatments.
• OPUS: U.S. based Observational Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice – The purpose of the OPUS registry is to better understand the use of Opsumit® in clinical practice and to characterize the clinical course of patients who are initiating treatment. NCT02126943
• SPHERE: Uptravi® (Selexipag): The users drug registry – The goal of the SPHERE registry is to better understand the use of Uptravi® in patients, how it is prescribed, and the clinical course of patients who are treated with this medication.
• INCREASE: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease – The objective of this study is to determine if inhaled Treprostinil vs placebo is safe and effective in treating Pulmonary Hypertension due to Parenchymal Lung Disease. NCT02630316
• TRITON: The Efficacy and Safety of Initial Triple vs Dual Oral Combination Therapy in Patients with Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-Center, Double-Blind, Placebo-Controlled, Phase 3B Study – The objective of this trial is to compare the effectiveness and safety of using 3 approved pulmonary hypertension (PAH) medications (Uptravi®, Opsumit®, and Adcirca) together vs 2 approved PAH medications (Opsumit® and Adcirca) for newly diagnosed patients who have not started medicine. NCT 0255831
• Quality of Life in Pulmonary Hypertension – The study aims to develop a new patient reported clinical trial outcome for patients with pulmonary hypertension.
• CRAB-PH: Correlation Between Estimated Right Atrial Pressure and BNP in Pulmonary Hypertension – This study is to evaluate if using an ultrasound to check how your pulmonary hypertension is affecting your heart is just as accurate as drawing a blood sample (BNP) during clinic visits. NCT02873039
• GRASP (Genome Research in African-American Scleroderma Patients) – The objective of this study is to assess the severity of scleroderma in association with genetics in people of African descent to ultimately develop targeted treatment.
• Development of the Mawdsley Calcinosis Index in Systemic Sclerosis – This study aims to develop the first Patient Reported Outcome Measure of calcinosis, which is a disabling complication of scleroderma.
• Raynaud’s Assessment Scale Development – This study aims to develop a novel patient reported clinical trial instrument for Raynaud’s phenomenon.
• Scleroderma Diet Randomised Controlled Trial – A randomized controlled trial investigating the impact of food choices on scleroderma symptoms
• SENSCIS (Safety and Efficacy of Ninedanib in systemic sclerosis) – This trial is assessing the effectiveness of nintedanib for scleroderma patients with lung fibrosis. NCT 02597933
• EUSTAR - DeSSipher – This is a global registry of scleroderma patients.
• ReAS (Registry for advanced sarcoidosis)
• ReSaPH (Registry of sarcoidosis-associated pulmonary hypertension) – This multi-center registry study of sarcoidosis associated pulmonary hypertension (SAPH) will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of SAPH. NCT 01467791

For more information about the research studies at our center, browse www.clinicaltrials.gov and search the NCT number provided.

Completed trials within the last two years

There have been some notable clinical studies performed in recent years.

Some of these include:

• Endothelial microparticles as a biomarker of pulmonary hypertension in systemic sclerosis
• AMBITION – A randomized, double blind, placebo-controlled, multi-center study of first line
  Ambrisentan and Tadalafil combination therapy in subjects with pulmonary arterial hypertension
• MOTION – A Phase IV, Prospective, Single-Arm, Open-Label to Measure Outcomes in Patients with Pulmonary Arterial Hypertension not on active treatment
• PHAROS (Pulmonary Hypertension Assessment and Recognition of Outcomes in Scleroderma) – This national registry study enrolled scleroderma patients with pulmonary hypertension and those at risk for pulmonary hypertension to characterize the progression and outcome of disease. NCT 003377949