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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)
This is a multi center registry of sarcoidosis associated pulmonary hypertension (SAPH). With this registry, the investigators will characterize the demographics, clinical course, hemodynamics, pulmonary physiology, and disease management of sarcoidosis associated pulmonary hypertension on the United States. The investigators will also compare these features to non-US sites.
Unknown status | High Blood Pressure / Hypertension | Not Multisite
Robert Baughman
US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice
Recruiting | High Blood Pressure / Hypertension | Multisite
V McLaughlin
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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CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy will be evaluated.
Recruiting | High Blood Pressure / Hypertension | Site Unknown
CVRx BAROSTIM NEO Hypertension Pivotal Trial
Suspended | High Blood Pressure / Hypertension | Multisite
George Bakris
Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients With Metastatic HER-2+ Breast Cancer, Phase III
PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. II. To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events. III. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population. IV. To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction. V. To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons. TERTIARY OBJECTIVES: I. To evaluate the isoleucine (lle) 655 valine (Val) and and alanine (Ala)ll70 proline (Pro) single nucleotide polymorphisms (SNPs) of the HER-2 gene as a predictive biomarker of study-defined cardiac dysfunction. II. To evaluate plasma neuregulin-1 at baseline and over study time as a predictive biomarker of study-defined cardiac dysfunction. III. To evaluate the feasibility of performing serial left ventricular strain in a National Clinical Trials Network (NCTN) group setting, with the goal of 75% of patients contributing both a baseline and at least one follow-up strain measurement. IV. To bank blood for future translational medicine studies such as brain natriuretic peptide (BNP), additional SNPs, and high sensitivity troponin. OUTLINE: Patients are randomized to 1 of 2 arms. Patients taking beta blocker, ARB, or ACE inhibitor at registration are assigned to Arm III. ARM I: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive carvedilol orally (PO) twice daily (BID). Courses repeat every 12 weeks for 108 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients not taking beta blocker, ARB, or ACE inhibitor at registration receive no study intervention for up to 108 weeks. ARM III: Patients undergo observation for up to 108 weeks. After completion of study, patients are followed up for up to 108 weeks.
Open | High Blood Pressure / Hypertension | Multisite
Justin Floyd
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