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Study Title Principal Investigator
Assessing the safety and efficacy of Macitentan in patients with portopulmonary hypertension
Several drugs (blood vessel dilators), including macitentan, are currently approved for the treatment of pulmonary arterial hypertension (PAH) in many parts of the world. These drugs have significantly improved the outcome of the condition. However, none of these treatments have been evaluated in portopulmonary hypertension, a form of PAH caused by liver disease. The purpose of this study is to assess the safety and effectiveness of macitentan in portopulmonary hypertension by looking at several clinical indicators, including the pressures within the arteries of the lungs and a person’s capacity for exercise.
Recruiting | High Blood Pressure / Hypertension | Not Multisite
Dr. Sivagini Ganesh
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Multicenter, Controlled, Randomized, Safety and Pharmacokinetic Study Comparing Intracisternal EG-1962 to Standard of Care Enteral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage
Not yet recruiting | High Blood Pressure / Hypertension | Site Unknown
R. Macdonald
A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension
Recruiting | High Blood Pressure / Hypertension | Multisite
Sivagini Ganesh
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Pulmonary Arterial Hypertension (PAH) Quality Enhancement Research Initiative (QuERI) Extension Program
This is a prospective, U.S.-based, multi-center, knowledge translation program tracking patient management until approximately early 2018. To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC). The goal of the optimal functional class is to improve WHO functional class III and IV patients to functional class I or II, and to improve all functional class II patients to functional class I, or at least to maintain functional class I/II in patients presenting in that functional class. Endpoints:1. Proportion of patients achieving guideline-recommended treatment at each documented visit.2. Proportion of patients achieving optimal functional class using an evidence-based reatment algorithm.3. Proportion of patients on various therapies in relation to their WHO functional class.4. PAH management (use of therapies) by physicians across patient risk strata based on FC.5. Association between treatment and physician and patient adherence with recommended treatment.6. Utilization of Knowledge Translation Program system reminders, and response by the physicians when asked for reasons evidence based therapy was not utilized.7. Survival by FC (baseline and change), etiology, prevalent vs incident, academic vs community, adherence and reminders.Descriptive analysis of demographic variables, physical exam, medical history and treatment profile will be performed as appropriate. Confidence Intervals (95%) will be calculated for descriptive and comparative purposes.
Recruiting | High Blood Pressure / Hypertension | Multisite
Sivagini Ganesh
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A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Active, not recruiting | High Blood Pressure / Hypertension | Multisite
Alain Romero
Registry of Sarcoidosis Associated Pulmonary Hypertension (RESAPH)
Pulmonary hypertension and resulting elevated right atrial pressure are associated with increased mortality in sarcoidosis patients awaiting lung transplantation. With the advent of new vasodilator drugs effective for pulmonary hypertension, interest has risen in treating pulmonary hypertension due to secondary causes, including sarcoidosis. We propose to develop a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, we will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension in the United States. Primary objective is to characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. Secondary objective is (1) Determine what factors are associated with a bad prognosis in patients diagnosed with SAPH (2) Determine if there is a difference in survival in patients treated with different management strategies (3) Determine the role of immunosuppressive therapy in management of SAPH. Endpoints are (1) Progression of disease to death or transplant (2) Hospitalization (3) Institution of new therapy for pulmonary hypertension (4) Six minute walk distance (5) Change in Saint George Respiratory Questionnaire of >4 points. This is an open label registry consisting of two populations of patients with SAPH. One group will be patients with known SAPH who are under care at the study center. The second group will be a prospective study of newly diagnosed cases of SAPH. The goal of the registry will be to include approximately 150 patients in both groups for a total of 300 patients.
Recruiting | High Blood Pressure / Hypertension | Not Multisite
Sivagini Ganesh
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US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Recruiting | High Blood Pressure / Hypertension | Multisite
V McLaughlin
Barostim Hypertension Pivotal Trial
High blood pressure can lead to serious medical problems including heart attack, stroke and kidney failure. There is a need for more effective treatments for high blood pressure especially in patients with difficult to control blood pressure. The purpose of this study is to evaluate the investigational device called the Neo system, in patients with resistant high blood pressure. The Neo system includes the following components: an implantable pulse generator and a carotid sinus lead. The lead of the device is placed alongside the baroreceptor in the carotid artery (this is an area that is important in blood pressure control). The carotid lead attaches to an implantable pulse generator placed under the skin of the chest. As blood pressure increases the pulse generator sends pulses to the carotid leads, stimulating the baroreceptors to counteract the rise in blood pressure. This study is a prospective, randomized trial in which the device will be compared with medical therapy. Participants will be randomized in a 1:1 ratio to receive a device plus optimal medical management or to receive optimal medical management alone. Participants will be followed over three years to determine the safety of the device (collect adverse event data) and the efficacy of the device (comparing control of systolic blood pressure to medical management). Statistical analysis will be performed to determine address the objectives safety by comparing adverse events between the two groups and efficacy by comparing blood pressure control.
Active, not recruiting | High Blood Pressure / Hypertension | Multisite
Vincent Rowe
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A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.
Completed | High Blood Pressure / Hypertension | Multisite
Sivagini Ganesh
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