Advertisement

Topics

Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction

2014-08-27 03:39:12 | BioPortfolio

Summary

The purpose of this study is to compare the effects of switching from inhaled Ventavis to intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis therapy. This study is intended to provide information on the safe transition from Ventavis to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life and treatment satisfaction compared to Ventavis.

Description

Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve quality of life (QOL).

Remodulin (treprostinil sodium), a prostacyclin analog, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Remodulin is an approved pharmacotherapy for PAH delivered as either a continuous subcutaneous infusion or intravenous infusion. Ventavis (iloprost)is an inhaled prostacyclin analogue with similar properties to Remodulin. In December 2004, Ventavis was approved for use in the United States by the FDA for the treatment of pulmonary arterial hypertension (WHO Group I) for patients with NYHA III or IV symptoms.

As the PAH community gains experience with the use of inhaled Ventavis, questions have arisen as to how to transition a patient on inhaled Ventavis to Remodulin in the presence of worsening symptoms or at a patient's request related to dissatisfaction with the frequency of daily treatments. This study will examine effects of switching from Ventavis to IV Remodulin and compare changes in exercise capacity, safety, HRQOL and treatment satisfactions.

Participation will last up to 12 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participates will have 4 clinic visits during the study and will spend at least one night in the hospital.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hypertension, Pulmonary

Intervention

treprostinil sodium

Location

UCSD Medical Center Thornton Hospital
La Jolla
California
United States
92037

Status

Terminated

Source

United Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:39:12-0400

Clinical Trials [2598 Associated Clinical Trials listed on BioPortfolio]

Effects of Inhaled Treprostinil Sodium for the Treatment of Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

The purpose of this study is to establish single-dose tolerability of inhaled treprostinil sodium in IPF patients with pulmonary hypertension, and to explore the acute hemodynamic effects ...

EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension

This is a multicenter, open-label study to evaluate the dose of Orenitram® (treprostinil) Extended Release Tablets achieved at 16 weeks after a short-term course of Remodulin® (treprosti...

Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis...

Safety and Tolerability of Inhaled Treprostinil in Adult PH Due to COPD

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 Obstr...

Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension

Our hypothesis is that IV or SQ Treprostinil can improve 6 minute walk distance, hemodynamics and quality of life in patients with interstitial lung disease and severe secondary pulmonary ...

PubMed Articles [5703 Associated PubMed Articles listed on BioPortfolio]

Inhaled Treprostinil in Pulmonary Hypertension Associated with Lung Disease.

Pulmonary hypertension (PH) in the setting of parenchymal lung disease adversely affects quality of life and survival. However, PH-specific drugs may result in ventilation/perfusion imbalance and curr...

Out of proportion pulmonary hypertension in obstructive lung diseases.

Pulmonary hypertension is common (25-90%) in chronic obstructive pulmonary diseases (COPDs). Severe pulmonary hypertension, however, is quite rare (1-3%). The term 'out of proportion' pulmonary hypert...

Evaluation of the effects of RP5063, a novel, multimodal, serotonin receptor modulator, as single-agent therapy and co-administrated with sildenafil, bosentan, and treprostinil in a monocrotaline-induced pulmonary arterial hypertension rat model.

Pulmonary arterial hypertension (PAH), a condition that is defined by pulmonary vasculature constriction and remodeling, involves dysfunctional signaling of the serotonin (5-HT) receptors, 5-HT. In a ...

Inhalation of repurposed drugs to treat pulmonary hypertension.

Pulmonary arterial hypertension (PAH) is a rare, but severe and life-threatening disease characterized by vasoconstriction and remodeling of the pulmonary arterioles, leading to progressive increase i...

The importance of left heart disease as a cause of pulmonary hypertension in COPD.

Chronic obstructive pulmonary disease is a common respiratory condition that presents in varying degrees of severity and can be complicated by further co-morbidities. Up to a third can also have pulmo...

Medical and Biotech [MESH] Definitions

A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).

Hypertrophy and dilation of the RIGHT VENTRICLE of the heart that is caused by PULMONARY HYPERTENSION. This condition is often associated with pulmonary parenchymal or vascular diseases, such as CHRONIC OBSTRUCTIVE PULMONARY DISEASE and PULMONARY EMBOLISM.

Familial or idiopathic hypertension in the PULMONARY CIRCULATION which is not secondary to other disease.

A multisystemic disorder characterized by a sensorimotor polyneuropathy (POLYNEUROPATHIES), organomegaly, endocrinopathy, monoclonal gammopathy, and pigmentary skin changes. Other clinical features which may be present include EDEMA; CACHEXIA; microangiopathic glomerulopathy; pulmonary hypertension (HYPERTENSION, PULMONARY); cutaneous necrosis; THROMBOCYTOSIS; and POLYCYTHEMIA. This disorder is frequently associated with osteosclerotic myeloma. (From Adams et al., Principles of Neurology, 6th ed, p1335; Rev Med Interne 1997;18(7):553-62)

A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

More From BioPortfolio on "Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary Hypertension
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of affected individuals. Symptoms can range from mild breathles...

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Blood
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...


Searches Linking to this Trial