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A Biorepository to Study Portopulmonary Hypertension
Rochester, Minn.
We propose to develop a biorepository of plasma samples from patients with suspected and confirmed portopulmonary hypertension to improve our understanding of this disease and its response to pulmonary arterial hypertension targeted therapy and liver transplantation.
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A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients (Liquidia)
Rochester, Minn.
The primary objective of this study is to evaluate the long-term safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).
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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study with Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an Add-on to Standard of Care Therapy in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment Chronic Thromboembolic Pulmonary Hypertension (SELECT)
Rochester, Minn.
The purpose of this study is to assess the effectiveness and safety of Selexipag in subjects with inoperable or persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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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
Jacksonville, Fla.,
Rochester, Minn.
This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).
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A Phase 1 Proof-of-Concept Clinical Trial Evaluating the Safety and Tolerability of Midodrine in Hepatopulmonary Syndrome
Rochester, Minn.
The purpose of this study is to assess the safety and tolerability of midodrine in patients with Hepatopulmonary Syndrome (HPS).
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A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients (INSPIRE)
Rochester, Minn.
The primary objective of this study is to evaluate the long-term safety and tolerability of LIQ861, a dry powder formulation of treprostinil, in patients with Pulmonary Arterial Hypertension (PAH). A secondary objective of this study is to evaluate the comparative bioavailability of treprostinil between two formulations of inhaled therapy.
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A Prospective, Multicenter Study for the Identification of Biomarker Signatures for the Early Detection of Pulmonary Hypertension (PH) (CIPHER)
Rochester, Minn.,
Jacksonville, Fla.
The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood and on exhaled volatile organic compounds (VOC) in the breath associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.
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An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity (CARE PAH)
Rochester, Minn.
The purpose of this study is to describe the time to all-cause death and time to death due to pulmonary arterial hypertension (PAH) or first hospitalization due to PAH in the overall study population and within each cohort.
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An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease
Jacksonville, Fla.,
Rochester, Minn.
This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
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Feasibility of Home-based Pulmonary Rehabilitation with Remote Monitoring in Pulmonary Arterial Hypertension (PAH)
Rochester, Minn.
The aim of this study is to evaluate the effects of a home-based program with health coaching of dyspnea and exercieses in subjects with pulmonary arterial hypertension (PAH).
Pulmonary rehabiltation has been shown to be an effective treatment for patients with chronic obstructive pulmonary disease, however there is currently a paucity of evidence to extrapolate this informaiton with patients with pulmonary arterial hypertension (PAH). In addition, there are no options outside of center-based pulmonary rehabilitation which have been proposed as an effective treatment option for patients with PAH.
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Initial Evaluation of the Pulmonary Hypertension Functional Class Self Report
Rochester, Minn.
The purpose of this study is to evaluate the Pulmonary Hypertension Functional Class Self Report (PHFC-SR) ratings for a sample of subjects with pulmonary hypertension (PH).
A secondary purpose is to explore the concordance between the patient-reported PH-FC-SR and clinician-assessed World Health Organization Functional Classification (WHO-FC) measure in a sample of subjects with PH, and to assess the construct validity between the patient-reported PH-FC-SR and a patient-reported disease-specific measure and a general health-related quality of life (HRQOL) measure.
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Letrozole in Patients with Hepatopulmonary Syndrome: A Double-Blind Randomized Clinical Trial
Rochester, Minn.
The purpose of this study is to determine whether letrozole affects alveolar-arterial oxygen gradient (AaPO2) at 6 months in patients with hepatopulmonary syndrome (HPS).
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Pulmonary Hypertension and Chronic Kidney Disease (PH and CKD)
Rochester, Minn.
The aims of this study are to establish a registry and biorepository of patients with PH-CKD, and to identify clinical risk factors and biomarkers associated with PH-CKD and different hemodynamic phenotypes.
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Quality of Life Assessed with the PAH SYMPACT Questionnaire in the Pulmonary Hypertension Clinic
Rochester, Minn.
The primary purpose of this study is to administer the PAH SYMPACT questionnaire in 200 consecutive eligible patients attending the Mayo Clinic pulmonary hypertension clinic. An additional patient satisfaction survey will be administered for patients that completed a palliative care consult.
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US-Based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice (OPUS)
Rochester, Minn.
The purpose of this registry is to characterize the safety profile (especially potentially serious risks to the liver) and describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.
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