An Open-label Extension Study of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) Associated with Heart Failure with Preserved Ejection Fraction (HFpEF) - A Long-Term Follow-up to Study TDE-HF-301 Save

Date Added
July 25th, 2017
PRO Number
Pro00068812
Researcher
Rahul Argula
Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to see how oral treprostinil works to treat PH associated with HFpEF. Oral treprostinil (brand name Orenitram) was approved by the United States Food and Drug Administration (FDA) in December 2013 for the treatment of pulmonary arterial hypertension (PAH). PAH means that the blood vessels going from the right side of the heart to the lungs (pulmonary arteries) have higher than normal pressure. PAH is a specific type of PH.
This study will evaluate the long-term safety of oral treprostinil and the effects of continued therapy on the ability to exercise.

Institution
MUSC
Recruitment Contact
Kelly French
(843) 792-3169
frenchke@musc.edu

A Phase 3, Placebo Controlled, Double-blind, Randomized, Clinical Study to Determine Efficacy, Safety and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) versus Placebo in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH): INOvation-1 Save

Date Added
June 27th, 2017
PRO Number
Pro00067380
Researcher
Rahul Argula
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to determine if inhaled nitric oxide (study drug), when given and breathed through the INOpulse (investigational device), may help treat PAH.The drug being studied is ?inhaled nitric oxide? and the device being studied is called the ?INOpulse.? Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. However, inhaled nitric oxide, in combination with the INOpulse delivery device, is an investigational treatment of PAH and is not currently approved by the FDA or Health Canada.

Institution
MUSC
Recruitment Contact
Melissa Spears
843-792-2072
coole@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects with Pulmonary Hypertension (PH) in Heart Failure with Preserved Ejection Fraction (HFpEF) Save

Date Added
June 13th, 2017
PRO Number
Pro00065596
Researcher
Rahul Argula
Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

This study will look at the effect that oral treprostinil has on your ability to exercise and on the time that your PH associated with HFpEF remains stable, improves, or worsens. It will also evaluate the safety of using oral treprostinil to treat PH associated with HFpEF when added to your currently prescribed medication therapy.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

An Extended Access Program To Assess Long-Term Safety Of Bardoxolone Methyl In Patients With Pulmonary Hypertension Save

Date Added
May 23rd, 2017
PRO Number
Pro00066024
Researcher
Rahul Argula
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels (including reimbursement) or until patient withdrawal, whichever. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically. All patients in the study will follow the same visit and assessment schedule. Patients will be scheduled to be assessed in person during treatment at Day 1, Week 4, Week 24, and every 24 weeks thereafter.
Patients will also be assessed by telephone contact on Day 10. Day 1 for this extended access study should occur on the same day as the last visit in the controlled clinical study. Assessments required for both the last visit in the controlled study and Day 1 for this study should only be completed once.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-8092
rowle@musc.edu

A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (402-C-1504) Save

Date Added
November 8th, 2016
PRO Number
Pro00060520
Researcher
Rahul Argula
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) are eligible for this study. This double-blind, randomized, placebo-controlled trial will study the safety, tolerability, and efficacy of bardoxolone methyl in qualified patients with WHO Group I CTD-PAH. Qualified patients will be randomized 1:1 to either bardoxolone methyl or placebo to be administered once daily for 24 weeks. Depending on the length of the screening period, the length of time inolved in study procedures is approximately 32 to 44 weeks.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension Save

Date Added
October 18th, 2016
PRO Number
Pro00058433
Researcher
Rahul Argula
Keywords
Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Subjects with Pulmonary Arterial Hypertension (PAH) will be asked to have blood drawn at their standard of care visit. Children (11 years and older) and adults are eligible. This study is voluntary. Blood samples obtained and the associated blood products and clinical/genetic data will be in the research study for a minimum of five years.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

An Open-Label Extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease Save

Date Added
September 27th, 2016
PRO Number
Pro00057441
Researcher
Rahul Argula
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this research study is to provide or continue to provide inhaled treprostinil to eligible subjects who participated in the RIN-PH-201 study. The study will also investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema. This study will look at the ability to exercise after taking the study drug. Adults over the age of 18 are eligible. This study is voluntary and will last until you discontinue from the study or the study ends.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A Multicenter, 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 Save

Date Added
July 26th, 2016
PRO Number
Pro00057087
Researcher
Rahul Argula
Keywords
Drug Studies, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to investigate the safety and how well inhaled treprostinil works in subjects with pulmonary hypertension associated with interstitial lung disease or combined pulmonary fibrosis and emphysema. Adults over the age of 18 are eligible. Study requires at least 6 separate clinic visits over approximately a 20 week period.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

A Randomized, Double-blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) Save

Date Added
February 17th, 2015
PRO Number
Pro00038310
Researcher
Rahul Argula
Keywords
Autoimmune disease, Drug Studies, Immune System, Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH), Sarcoidosis, Scleroderma
Summary

Systemic sclerosis (SSc) or scleroderma is an autoimmune disease in which a person?s own immune cells attack his/her skin and internal organs, including the joints, lungs, heart, intestinal tract, and kidneys. The effects on the lungs, including pulmonary arterial hypertension (PAH), are among the most serious complications of SSc. In general, PAH is defined as an increase in pressure in the pulmonary arteries (the main blood vessels that lead from the heart to the lungs). Treatments for PAH have focused on symptom management rather than curing the disease.

This study has been designed to look at a new approach to treating the cause of the disease, rather than the symptoms of the disease. Recent research suggests that SSc-PAH may be the result of an ?attack? by immune cells. This study will look at the effect of the drug rituximab on the immune system and the immune ?attack? on the lungs. Rituximab is an immunosuppressive drug that eliminates the B cells for a few months, and therefore may halt the B cell attack on the lungs thought to be associated with this disease.The recovery of your B cells will be closely monitored throughout the study by blood testing.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

OPUS Registry Opsumit® (macitentan) USers Registry Save

Date Added
November 18th, 2014
PRO Number
Pro00039449
Researcher
Rahul Argula
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

Pulmonary arterial hypertension subjects who are new users of Opsumit®
can participate in this observational registry. All patients being prescribed to take Opsumit® will be invited to participate in the OPUS registry

The OPUS registry will collect information on patients newly treated with Opsumit® in the United States. If you agree to participate in the OPUS registry, information about your disease and the treatment of your disease will be collected for at least 1 year and stored electronically, from the date that you agree to enroll in the OPUS registry.

As this is an information-gathering study only, participating in the OPUS registry will not influence the usual care that you receive from your doctor.The data collected on patients will include retrospective data, if applicable (data from medical records that were recorded prior to start of the OPUS registry) and follow-up clinic visit data. Thereafter, your medical data will be collected when you see your doctor at routine visits, or during a potential hospitalization.

Institution
MUSC
Recruitment Contact
Elizabeth Poindexter
843-792-1820
poindex@musc.edu

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