A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of KER-012 in Combination with Background Therapy in Adult Participants with Pulmonary Arterial Hypertension (TROPOS Study)

Date Added
March 4th, 2024
PRO Number
Pro00134760
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This is a Phase 2, double-blind, randomized, placebo-controlled study of KER-012 (study drug) compared to Placebo in adult participants with a primary diagnosis of Pulmonary Arterial Hypertension (PAH) on stable background PAH therapy. About 90 participants, in approximately 60 study centers worldwide, will take part in this study. Participation in this study may last up to 2 years and the study has a Screening period, Treatment period, Extension period, and Follow-up period.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

Date Added
February 12th, 2024
PRO Number
Pro00134528
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This Phase 3 study, comprising a double-blind, placebo-controlled treatment period of up to 48 weeks, will assess the efficacy and safety of seralutinib versus placebo when added to background PAH disease-specific medication in adult PAH subjects who are WHO FC II or III. The primary objective of the study is to assess the efficacy of seralutinib relative to placebo with a primary endpoint of change from baseline to Week 24 in 6MWD.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System (ASPIRE PH)

Date Added
December 12th, 2023
PRO Number
Pro00131756
Researcher
Michele Esposito

List of Studies

Keywords
Pulmonary Hypertension
Summary

This clinical investigation is a prospective, non-randomized, single-arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The device will be implanted in the pulmonary artery and the gas reservoir of the device will be in the abdominal cavity. The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. Some procedures involved in the study include but not limited too: Questionnaires, physical exams, right heart catherization, echocardiograms, blood work and more. The study will be conducted in a maximum of 10 centers in the United States. Up to 45 patients will be consented, and up to 15 patients will receive implants. There is a total of 11 visits over the course of 2.5 years for the study. Because this is an investigational device under the FDA, there may be risk that include but are not limited to: arrhythmia, device infection, endocarditis, and heart failure. If the Aria CV device performs as intended, you may potentially benefit from reduction in or relief of symptoms caused by PH, and depending on your overall health conditions, prolonged life expectancy and/or improvement in your overall quality of life.

Institution
MUSC
Recruitment Contact
Shaquanda Ross-Simmons
843-876-5783
shr37@musc.edu

3P-100-ILD-00 Early Feasibility Study Protocol: A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety, Tolerability, and Functionality of 3P-100, an Electric Nitric Oxide (NO) Ambulatory Production and Delivery System, Delivering Nitric Oxide for Inhalation to Subjects with Pulmonary Hypertension (PH) Accompanying Interstitial Lung Disease (ILD), PH-ILD

Date Added
October 31st, 2023
PRO Number
Pro00128998
Researcher
Rahul Argula

List of Studies


Keywords
Interstitial Lung Disease (ILD), Lung, Pulmonary Hypertension
Summary

This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO for the treatment of subjects with PH-ILD. All subjects will use the 3P-100 device and receive iNO via the 3P-100 device, aiming for ~4-4.5 hours of treatment. All subjects will remain on their prescribed Oxygen (O2). The study consists of an SV, an iNO treatment period at V1 (Day 0), and a Telephone Call at V1 + 1 Day for safety follow-up.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 4, Prospective, Multicenter, Single-Arm Study of a Mean Pulmonary Artery Pressure-Targeted Approach with Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Patients with Pulmonary Arterial Hypertension: ARTISAN (Afterload Reduction To Improve Right Ventricular Structure And FuNction)

Date Added
October 5th, 2023
PRO Number
Pro00129381
Researcher
Rahul Argula

List of Studies


Keywords
Critical Care, Pulmonary Hypertension
Summary

This is a phase 4, prospective, multicenter, single-arm, open-label study designed
to evaluate the effect of early and rapid treprostinil therapy on mean pulmonary artery pressure (mPAP) reduction to improve Right ventricular (RV) function and reverse RV remodeling in patients with PAH. This study will use the CardioMEMS™ HF System (CardioMEMS) to measure and monitor mPAP, but may allow mPAP monitoring via RHC (right heart catheterization), if CardioMEMS is NOT available at a subject's Baseline Visit (Day 1) or if the CardioMEMS™ PA Sensor implantation is unsuccessful.

Participation is expected to be up to 37 months and will include about 10 office visits to the study doctor. This will be divided up into a 30-day Screening Period, a 12-month Treatment Period, and a 24-month Extended Treatment Period.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A randomized, participant- and investigator-blinded, placebo-controlled study to investigate efficacy, safety and tolerability of LTP001 in participants with pulmonary arterial hypertension

Date Added
July 6th, 2023
PRO Number
Pro00128867
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This study is exploring the safety and efficacy of the study drug LTP001 in subjects with pulmonary arterial hypertension. This is a randomized study and the subjects will be be given the study drug or placebo in a capsule form which they are to take once daily in the morning. Participants will be screened for up to 8 weeks followed by 24 weeks of daily dosing- study visits to the site will occur approximately every 4 weeks. During these study visits there will be study procedures that may include labs for blood and urine, ECGs, vital signs, 6MWD, echocardiogram, or right heart catherization. There is the opportunity for an open-label portion of the study as well.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 2, Double-blind, Randomized, Placebo controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
April 12th, 2022
PRO Number
Pro00119299
Researcher
Daniel Silverman

List of Studies

Keywords
Heart, Pulmonary Hypertension, Shortness of Breath
Summary

The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 66:33 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUSTM Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch: TRIOMPHE

Date Added
February 14th, 2022
PRO Number
Pro00115968
Researcher
Ravi Veeraswamy

List of Studies


Keywords
Heart, Pulmonary Hypertension, Vascular
Summary

The purpose of this research study is to continue to test how well the Endospan NEXUSTM Aortic Arch Stent Graft System performs in the treatment of a diseased aortic arch. The aortic arch is the top part of the main large vessel that carries blood away from the heart. A stent graft is a self-expanding frame that is covered with a material intended to seal the vessel walls.
The NEXUS Aortic Arch Stent Graft System is delivered to the diseased area of your aorta by traveling through your vascular system using fluoroscopic guidance (x-ray pictures), starting with a small incision or needle puncture near your groin (inner thigh). The NEXUS Aortic Arch Stent Graft System is being studied and is not approved by the FDA which means it is investigational in this study. The NEXUS Aortic Arch Stent Graft System has CE Mark which means it is approved for use in Europe. The NEXUS Aortic Arch Stent Graft System is only available through the clinical study in the United States.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate Sotatercept When Added to Maximum Tolerated Background Therapy in Participants With Pulmonary Arterial Hypertension (PAH) World Health Organization (WHO) Functional Class (FC) III or FC IV at High Risk of Mortality

Date Added
January 20th, 2022
PRO Number
Pro00115261
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The objective of this study is to evaluate the effects of sotatercept treatment (plus maximum tolerated background PAH therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥ 24 hours, in participants with WHO FC III or FC IV PAH at high risk of mortality. The study targets patients with symptomatic PAH (WHO FC III or FC IV at high risk of mortality) who present with idiopathic or heritable PAH, PAH associated with connective tissue diseases (CTD), drug- or toxininduced, post-shunt correction PAH, or PAH presenting at least 1 year following the correction of congenital heart defect. Up to 166 participants will be randomly assigned in a 1:1 ratio to the
2 study treatment groups (83 participants per arm). Maximum study duration for a given participant in this study will be up to approximately 49 months.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate-and High-Risk PAH Patients

Date Added
October 6th, 2021
PRO Number
Pro00113186
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The objective of this study is to evaluate the effects of sotatercept treatment (plus background PAH therapy) verses placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are in intermediate or high risk of disease progression. The study is divided into a Screening Period (up to 4 weeks), followed by a Double-blind Placebo-controlled (DBPC) Treatment Period. When a participant experiences an event of clinical worsening, they will complete the End of Treatment (EOT) Visit and will be eligible to enroll immediately in the open-label, long-term follow-up (LTFU) study, A011-12 (SOTERIA). Up to 662 participants will be randomly assigned in a 1:1 ratio to the 2 study treatment groups (331 participants per arm).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu



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