View clinical trials related to Pulmonary Arterial Hypertension.
Filter by:The purpose of this study is assess whether ambrisentan can help people with exercise- induced pulmonary arterial hypertension (EIPAH). The investigators also want to find out if ambrisentan is safe to take without causing excessive side effects.
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
The primary objective of this study is to assess the safety and tolerance of changing patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.
The objectives of the current study are to identify and evaluate new prognostic non-invasive and serological markers in patients with pulmonary hypertension. The focus will be on L-arginine metabolism and to clarify its influence on endothelial function.
The purpose of this study is to assess tolerability and clinical effects of transition from intravenous (IV, needle in the vein) or subcutaneous (SQ, needle in the skin) to the recently-approved inhaled treprostinil (Tyvaso) for the treatment of pulmonary arterial hypertension (PAH). Our hypothesis is that the transition to inhaled treprostinil will be tolerated by patients. The intravenous and subcutaneous drugs epoprostenol and treprostinil received approval for treatment of PAH many years ago. While these medications improve exercise capacity and the symptoms of PAH, they are given by injection and thus have several side effects, such as pain and catheter infection. This has resulted in many patients either refusing to take the medication or quitting these medications because of not tolerating them. The only other form of prostacyclin treatment available for PAH patients is inhaled. There are 2 inhaled prostacyclins approved for PAH, however one of these requires at least 6 inhalations per day, every day, and takes about 30 minutes to inhale each time. Thus, it has not been a regularly-used medication and issues surrounding compliance make it a riskier drug to use if patients do not get their full doses every day. The other inhaled medication, treprostinil, was approved a few months ago, only needs to be given 4 times a day, and takes about 2-3 minutes to inhale. Since inhaled treprostinil can be administered easily, it is anticipated that many patients will transition from epoprostenol or treprostinil to the recently approved inhaled treprostinil, however we do not know if this is a safe or effective way to manage patients. Thus, the goal of this prospective study is to gather observational data regarding how that switch is made, tolerability of the switch, and, to the extent possible with this methodology, assess clinical effects of the switch. This is a prospective study. Twenty patients > 18 years old with PAH will be enrolled. Patients enrolled will be those in whom a clinical decision to convert from either IV epoprostenol, IV treprostinil, or SQ treprostinil to inhaled treprostinil therapy has been made. This is usually the result of patients asking to switch to inhaled therapy, but only allowed by physicians if they feel the switch would be safe. If eligible, and after informed consent, patients will have a history and physical examination, a 6 min walk test, a cardiopulmonary exercise test (CPET), blood tests, and a symptom questionnaire will be filled out. Patients will then be admitted to the hospital where a monitoring catheter will be placed inside the patient's heart and inhaled treprostinil will be initiated, while the dose of IV/SQ medication is reduced over about 24-26 hours. Clinical follow-up will be at weeks 1, 4, and 12. The procedures above are all part of the routine clinical care that patients would receive if they were to be transitioned to inhaled therapy, including the hospitalization and catheterization. The criteria for them to be able to be switched are conservative. Pressure in their heart and lungs must be low (mPAP < 40 mmHg and RAP <12 mmHg on catheterization), and their dose of IV or SQ medication must be low (< 20 ng/kg/min). Regarding the patient subset enrolled in this study in whom a clinical decision to convert transition therapy has been made, we will try to ensure that our clinical decision-making will not be influenced by the need to enroll subjects in the study by explicitly noting the potential for conflict of interest with each patient (addressed in the ICF). We will not make a clinical decision for our patients based on the desire to fill the study numbers, and every will be made to avoid the potential for a perceived conflict of interest.
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
A Phase 2 open label, dose escalation study to find the minimally and maximum effective dose (dose beyond which no further effect on PVR is seen) of inhaled nitric oxide generated by the GeNOsyl® System compared to placebo.
Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
The investigators have recently evidenced the presence of antibodies to endothelial cells and fibroblasts in patients with idiopathic or SSc-associated PAH. The investigators also have identified several target antigens of anti-fibroblasts antibodies. The objective of this study is to further investigate for the presence of antibodies to endothelial cells and fibroblasts in patients and characterize the antigen specificity of autoantibodies in patients with different types of non idiopathic and non SSc-associated PAH, such as PAH associated with HIV infection, porto-pulmonary hypertension, congenital heart diseases, systemic lupus erythematosus, mixed connective tissue disease and Sjögren's syndrome