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Pulmonary Hypertension clinical trials

View clinical trials related to Pulmonary Hypertension.

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NCT ID: NCT00492531 Terminated - Sickle Cell Disease Clinical Trials

Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease

Start date: June 2007
Phase: Phase 2
Study type: Interventional

This study will examine whether the drug sildenafil can lower blood pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) in patients with sickle cell disease and pulmonary hypertension (high blood pressure in the lungs). It will see if this treatment can reduce disease complications, such as shortness of breath, pain crisis, pneumonia, and increase survival. Patients 12 years of age and older with sickle cell disease and pulmonary hypertension may be eligible for this study. Participants are randomly assigned to receive sildenafil or placebo (sugar pill) for 16 weeks. Before starting treatment, patients have baseline studies, including a pregnancy test for females of childbearing age; a chest x-ray; pulmonary function tests to measure how much air the patient can breathe in and out; an echocardiogram (heart ultrasound); a 6-minute walk test to measure exercise capacity; a quality-of-life assessment and a pain inventory. Patients with moderate to severe pulmonary hypertension undergo heart catheterization to evaluate the severity of hypertension before beginning sildenafil therapy. During treatment, patients are monitored with the following: - Blood tests: weeks 6, 10 and 16. - Echocardiogram: weeks 6 and 16. - 6-minute walk test: weeks 6, 10 and 16. - Measurements of weight, blood pressure and heart rate: weeks 6, 10 and 16. - Pregnancy test for women of childbearing age: weeks 6, 10 and 16. - Pain questionnaire once a day for a week: weeks 6 and 1.0 - Quality-of-life questionnaire: week 16. - Heart catheterization: week 16 for patients with moderate to severe hypertension. At the end of the 16-week period, patients may opt to continue to receive sildenafil and monitoring in an open-label phase of the study for up to 1 year.

NCT ID: NCT00467896 Terminated - Clinical trials for Pulmonary Hypertension

The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

Start date: September 2006
Phase: Phase 2
Study type: Interventional

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

NCT ID: NCT00409526 Terminated - Clinical trials for Pulmonary Hypertension

Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.

Start date: December 2006
Phase: Phase 4
Study type: Interventional

Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary Hypertension of the Newborn in two different doses in order to test safety and efficacy in reducing pulmonary artery pressure.

NCT ID: NCT00377455 Terminated - Clinical trials for Pulmonary Hypertension

Placebo Controlled Trial of Bosentan in Scleroderma Patients

Start date: September 2006
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the drug Bosentan improves exercise tolerance in scleroderma patients.

NCT ID: NCT00360087 Terminated - Clinical trials for Pulmonary Hypertension

A Study of Patients Having Pulmonary Hypertension Associated With Sickle Cell Disease and Completing an ASSET Study

ASSET-3
Start date: March 2006
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of bosentan therapy (in a study known as ASSET) for patients who have high blood pressure in the lungs associated with sickle cell disease. That form of hypertension places people at risk for complications, including shortness of breath, pain, pneumonia, and death. Previous studies have shown that bosentan can be helpful in reducing pulmonary hypertension. Patients ages 16 and older who have completed the 16-week treatment in the ASSET 1 or ASSET 2 study and who are not pregnant or breastfeeding may be eligible for this study. The research will be conducted in about 25 hospitals in the United States and Europe. Up to 30 participants will be enrolled. The screening visit will involve a physical examination, blood sample of about 3 teaspoons for laboratory tests, and a pregnancy test. Patients' doctors will give them bosentan tablets (62.5 mg each), to take one in the morning and one in the evening. After 1 month, patients will be told whether the dose should be increased to 125 mg tablets to take twice a day. Two weeks after the increase in dose, a blood test will be done to analyze the drug's effects on the liver. After the start of treatment, patients will return for visits every 6 months, when there will be a 6-minute walking test to measure exercise capacity and evaluate shortness of breath. There will be follow-up for patients up to the end of the study and for 28 days after the last dose of bosentan is taken, to collect information about side effects. Some patients on bosentan have had changes in liver function and red blood cell count. Side effects commonly reported are headache, flushed appearance, inflammation of the throat and nasal passages, and gastrointestinal symptoms. If patients have sudden worsening in breathing in the first few weeks after taking bosentan, they should immediately tell their doctors, because it may be necessary to change the treatment.

NCT ID: NCT00350844 Terminated - Sickle Cell Disease Clinical Trials

Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension

Start date: July 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease.

NCT ID: NCT00313196 Terminated - Clinical trials for Pulmonary Hypertension

Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients Diagnosed With Pulmonary Hypertension (PH)

ASSET-2
Start date: April 2006
Phase: Phase 3
Study type: Interventional

The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It consists of 3 phases: screening, treatment and follow-up. During the screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the baseline visit the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study some of the patients will be asked to repeat the right heart catheterization. All patients will repeat an exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.

NCT ID: NCT00310830 Terminated - Clinical trials for Pulmonary Hypertension

Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH)

Start date: March 2006
Phase: Phase 3
Study type: Interventional

The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.

NCT ID: NCT00302211 Terminated - Clinical trials for Pulmonary Hypertension

The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

VISION
Start date: February 1, 2006
Phase: Phase 3
Study type: Interventional

The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.

NCT ID: NCT00145938 Terminated - Clinical trials for Pulmonary Hypertension

Sildenafil and Pulmonary Artery Pressure

Start date: September 2003
Phase: Phase 2
Study type: Interventional

The purpose of the study is to see if the administration of sildenafil (Viagra) in patients with portopulmonary hypertension could be a safe and effective treatment. Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs. Pulmonary hypertension results from constriction, or tightening, of the blood vessels that supply blood to the lungs. Consequently, it becomes difficult for blood to pass through the lungs, making it harder for the heart to pump blood forward. This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues, such as in the legs. Affected patients can sometimes notice increasing shortness of breath and dizziness. There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding this area. Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an effective treatment for PTPH, especially in candidates for liver transplantation Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on pulmonary arterial pressure, safety, and tolerability in patients with PTPH