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Study of PAH Subjects with LTOT Use that have Demonstrated Improved Exercise Tolerance with the use of Inhaled Nitric Oxide
This randomized, controlled clinical pilot trial will evaluate the effects associated with in-office use of closed-loop, acoustic stimulation neurotechnology (High-resolution, relational, resonance-based, electroencephalic mirroring; HIRREM), compared with acoustic stimulation not linked to brainwaves (ambient nature sounds), for participants with pre-hypertension. Data collection will occur at baseline, and at intervals after completion of the intervention. Outcomes include blood pressure, measures of autonomic cardiovascular regulation, behavioral symptom outcomes, quality of life, alcohol use, and functional performance measures. The primary outcome will be change in blood pressure from baseline to 4-6 weeks after intervention.
The study objective is to build group social norms to improve individual adhere to antihypertensive medications. Financial incentives are provided to individuals contingent upon group behavioral changes. Groups of patients will be formed, and incentivized to interact on a daily basis through social media and participate in a monthly-facilitated meeting at a local clinic. By forming groups, making individual outcomes transparent, and setting financial incentives contingent to group targets, individual decisions are framed within emerging social norms.
This pilot, feasibility study evaluates the efficacy of sacubitril-valsartan (Entresto) versus usual anti-hypertensive medications in patients with left ventricular assist devices (LVAD). It also measures diurnal blood pressure variations in the context of continuous flow physiology.
The development of disease-targeted drugs for the treatment of pulmonary arterial hypertension (PAH) has significantly improved within the last years. Combining drug products with different mechanisms of action such as Endothelin-Receptor-Antagonists (ERAs) and Phosphodiesterase-Type-5-inhibitors (PDE-5-Inhibitors) has become increasingly important for the treatment of PAH. Recently, the results of the AMBITION study reported that an upfront combination treatment of ambrisentan and tadalafil immediately after diagnosis leads to a delayed disease progression. On the other hand, the sequential combination of bosentan and sildenafil did not show a similar positive clinical effect and this was attributed to a negative clinically relevant pharmacodynamic drug-drug interaction. Although, recent guidelines have extrapolated that initial upfront combination treatment follows a class effect in terms of efficacy and safety, there is an imperative need to support this notion with other combinations of ERAs and PDE-5-Inhibitors.
This is a multicenter, randomized (2:1; oral treprostinil:placebo), double-blind, placebo-controlled event-driven (time to pulmonary hypertension [PH] clinical worsening) study in subjects with PH associated with sickle cell disease (SCD). Once enrolled, subjects will be evaluated at Weeks 6, 12, 24, and then every 12 weeks for the duration of the study. Subjects will be permitted to enter a 48-week open-label extension period if they experience a PH clinical worsening event.
This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.
This is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with Chronic Obstructive Pulmonary Disease (COPD).
This is a multicenter, randomized (2:1 oral treprostinil: placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are currently receiving background dual therapy (ambrisentan, tadalafil) for at least 30 days at randomization for their PAH. Once randomized, subjects will return for 5 study visits up to Week 28 during the blinded period. After the Week 28 Visit, eligible subjects will transition to the open-label period of the study for up to 20 weeks.
The purpose of this study is to evaluate the efficacy and safety of TCV-116CCB (candesartan cilexetil and amlodipine besylate fixed-dose combination) in Chinese participants with mild to moderate hypertension who do not reach target blood pressure following 4 weeks of treatment with amlodipine monotherapy.