A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) Save

Date Added
January 8th, 2019
PRO Number
Pro00083949
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

This is a Phase 2 study to determine the efficacy and safety of an experimental study drug called sotatercept. Enrolled patients will receive either sotatercept or placebo (substance that is made to resemble drugs but does not contain an active drug) in combination with your current Pulmonary arterial hypertension (PAH) medication(s), which falls within currently accepted standard of care (SOC) for PAH. There are 4 parts to this research study, a screening period (28 days), a 6-month double-blind treatment period, an 18-month extension period, and an 8-week follow up period. If qualified to continue with treatment, the subject will receive subcutaneous (under the skin) injection(s) of the study treatment through a needle at each dosing visit (multiple injections may be required).

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

in Situ measurement of anti-apoptotic Phenotype in the pulmonary arterIal endothelium and its association with pRe-capillary disEase in Pulmonary Hypertension Save

Date Added
October 16th, 2018
PRO Number
Pro00081988
Researcher
Ryan Tedford

List of Studies

Silhouette
Keywords
Heart, Pulmonary Arterial Hypertension (PAH)
Summary

This study will involve subjects undergoing clinically indicated Right heart catheterization for either idiopathic pulmonary arterial hypertension (IPAH) or heart failure with preserved ejection fraction (HFpEF). The catheter tip utilized in the procedure, which would otherwise be discarded, will be collected and tested. A test performed on the cells adhered to the end of the catheters has been developed which we believe can aid in the differentiation of patients diagnosed with IPAH vs. HFpEF.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@musc.edu

Cardiac biopsies in pulmonary hypertension Save

Date Added
August 21st, 2018
PRO Number
Pro00077070
Researcher
Ryan Tedford

List of Studies

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Keywords
Pulmonary Arterial Hypertension (PAH), Scleroderma
Summary

Patients with systemic sclerosis (SSc) related pulmonary arterial hypertension (SScPAH) have a worse prognosis than those with idiopathic PAH. We have recently discovered that heart cells in SScPAH do not contract or squeeze as well as in other forms of pulmonary hypertension. However, the mechanism leading to this dysfunction is not understood. To better study this and in hopes of developing a future therapy, we plan to collect tissue samples via a heart biopsy at the time of a clinically indicated heart catheterization.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-792-1105
sykesb@musc.edu

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

List of Studies


Profiles_link
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 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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF IFETROBAN IN PATIENTS WITH DIFFUSE CUTANEOUS SYSTEMIC SCLEROSIS OR SYSTEMIC SCLEROSIS-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION Save

Date Added
October 11th, 2016
PRO Number
Pro00059217
Researcher
Richard Silver

List of Studies


Profiles_link
Keywords
Drug Studies, Pulmonary Arterial Hypertension (PAH), Scleroderma
Summary

A 52 week trial to evaluate the safety and effectiveness of the study drug ifetroban versus placebo, in treating patients with diffuse cutaneous systemic sclerosis or systemic sclerosis associated Pulmonary Arterial Hypertension. Subjects over age 18, with disease duration 60 months or less, along with other inclusion criteria will receive study drug or placebo for one year, along with safety testing.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@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

List of Studies


Profiles_link
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

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