Pulmonary Hypertension Association Registry (PHAR)

Date Added
March 18th, 2020
PRO Number
Pro00097483
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

The PHAR is a multicenter, prospective registry of newly evaluated patients at PHCCs in the United States who have either PAH or CTEPH. Baseline information will be collected at the time of initial evaluation at the PHCC (within six months of the initial outpatient PHCC visit) with follow-up data collected at approximately 6-month intervals. This study will determine how patients with PH are evaluated, tested, and treated, and will observe how well patients do. The goal of the project is to see if patients with PH are treated according to recommended guidelines and to see if there are certain factors which lead to better or worse outcomes in patients with PH. There is no intervention or study medication used and there is no limitation to how a patient is treated in this study.

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

An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH

Date Added
August 4th, 2021
PRO Number
Pro00111327
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This open-label, LTFU study will evaluate the safety, tolerability, and efficacy of sotatercept in participants with PAH previously treated with sotatercept or placebo. Participants eligible to enroll in this study will have participated in and completed the relevant study participants of the parent PAH sotatercept clinical trials. The estimated duration of the A011-12 study is up to 7 years; however, the estimated duration of enrollment for each participants is approximately 4 years. There is no formal sample size calculation for the study. The number of participants in this LTFU study is dependent upon the enrollment in the parent protocols. Approximately 700 participants are anticipated to enroll in the study.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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

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 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 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

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 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

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



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