Researchers in the Duke Division of Pulmonary, Allergy, and Critical Care Medicine are devoted to understanding the causes and mechanisms of pulmonary arterial hypertension. We are conducting a number of trials to test treatment options and medicines to combat this disease.
Current Clinical Trials
The following clinical research initiatives are being conducted in our division:
A011-12 : This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.
Principal Investigator: Terry Fortin, MD
Status: Recruiting
IRB Number: Pro00110303
Clinical Trials.gov #: NCT04796337
A Phase II, Randomized, Double-Blind, Safety and Efficacy Study of Tiprelestat Versus Placebo when Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tiprelestat plus Standard of Care (SOC) compared with placebo plus SOC in patients with World Health Organization (WHO) functional class II-IV pulmonary arterial hypertension (PAH).[
Principal Investigator: Sudarshan Rajagopal, MD
Status: NOT YET enrolling
IRB Number: Pro00119418
Clinical Trials.gov #: NCT07601295
Study Team Contact: Claudia.salazar@duke.edu • (919) 660-2026
A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH ILD)
The purpose of this study is to capture and analyze patient characteristics, treatment patterns, and clinical outcomes of patients with PH-ILD, with the goal of enhancing our current understanding of the disease state and its treatment outcomes. The study also aims to describe the disease trajectory of ILD patients at risk of pulmonary hypertension (PH).
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: Pro00116519
Clinical Trials.gov #: NCT06388421
Study Team Contact: carly.newman@duke.edu • (919) 668-2642
The specific goal of this project is to establish a resource of DNA and biochemical information on patients with CTEPH and acute PE. We will collect tissue and blood samples for DNA, biochemical markers and cellular materials for all consenting patients with CTEPH undergoing PTE surgery and acute PE patients undergoing catheter-directed therapies. This database of DNA, clinical characteristics, catheterization and echocardiographic findings, and biochemical markers will serve as a resource for the study of the association of genetic factors with CTEPH and acute PE with outcomes.
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: Pro00082338
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension
The purpose of this study is to evaluate the effectiveness and safety of the study drug, IKT-001, compared to placebo for pulmonary arterial hypertension (PAH).
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: Pro00118625
Clinical Trials.gov #: NCT07365332
Study Team Contact: elise.ayers@duke.edu • (919) 681-3791
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Arterial Hypertension (PALM-PAH)
The purpose of this study is to evaluate an experimental drug (Treprostinil Palmitil) for PAH patients.
Principal Investigator: Sudarshan Rajagopal, MD
Status: NOT YET enrolling
IRB Number: Pro00120434
Clinical Trials.gov #: NCT07481981
Study Team Contact: Claudia.salazar@duke.edu • (919) 660-2026
The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S.
PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes
Principal Investigator: Terry Fortin, MD
Status: Recruiting
IRB Number: Pro00102410
Clinical Trials.gov #: NCT04071327
Study Team Contact: carly.newman@duke.edu • (919) 668-2642
The main goal of this study is to develop a noninvasive signature for pulmonary vascular remodeling in Group 3 PH patients, using hyperpolarized 129Xe magnetic resonance imaging (129Xe MRI). Such a signature may identify Group 3 PH responders to PAH-specific therapies. PAH's unique 129Xe MRI signature has been shown in previous studies. Past studies have lacked a pathologic "ground truth" correlate of these signatures, which could be provided by comparing them with the pathology of lung explant tissue from patients who have undergone a lung transplant. This signature could be validated in a cohort of patients with Group 3 PH in future studies.The purpose of this study is to assess the safety and efficacy of Rodatristat Ethyl in pulmonary arterial hypertension (PAH) patients.
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: PRO00106221
Clinical Trials.gov #: NCT04778046
Study Team Contact: Claudia.salazar@duke.edu • (919) 660-2026
129Xenon MR Imaging and Spectroscopy Response to Sotatercept in Pulmonary Arterial Hypertension
The purpose of this study is to evaluate the ability of a new technology, called hyperpolarized xenon (129Xe) Magnetic Resonance Imaging (MRI), to monitor
changes in lung tissue and to determine how these changes may impact lung function in PH.
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: Pro00115215
Clinical Trials.gov #: NCT06351345
Study Team Contact:
chyla.keys-timmons@duke.edu • (919) 684-5257
Claudia.salazar@duke.edu • (919) 660-2026
The overall objective outlined in this study is to determine how pulmonary vascular remodeling in PAH at a cellular and pathological level is associated with changes in gas exchange physiology and hemodynamics (monitored with 129Xe MRI/MRS) and how these signals change with disease progression or treatment.
Principal Investigator: Sudarshan Rajagopal, MD
Status: Recruiting
IRB Number: Pro00107613
Clinical Trials.gov #: NCT04991454
Study Team Contact: Claudia.salazar@duke.edu • (919) 660-2026
129 Xenon MRi as a Biomarker for Diagnosis and Response To Therapy in Pulmonary Arterial Hypertension
The purpose of this study is to evaluate the ability of a new technology, called hyperpolarized xenon (129Xe) Magnetic Resonance Imaging (MRI), to monitor changes in lung tissue and to determine how these changes may impact lung function in PH.
Principal Investigator: Fawaz Alenezi, MD
Status: Recruiting
IRB Number: Pro00113893
Clinical Trials.gov #: NCT06104228
Study Team Contact: Claudia.salazar@duke.edu • (919) 660-2026
Enroll in a Pulmonary Clinical Trial at Duke
Researchers in our division are investigating a variety of treatments and therapies to respond to lung disease.
Click here to view a list of current clinical trials for Pulmonary.