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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: NCT00356265 Terminated - Hypertension Clinical Trials

Alpha-Adrenoceptor Vascular Function In Chronic Kidney Disease Focus On The Role Of Endothelial Nitric Oxide

Start date: July 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to learn more about why most patients with early stages of kidney disease have high blood pressure. We know the body produces natural substances that cause blood vessels to open wider to carry more blood when needed. An example is during exercise. Other natural substances cause blood vessels to get smaller and slow down blood flow when needed. An example is when people are cold. The balance between these substances is important. People with kidney disease and high blood pressure do not have the normal balance of these substances. This study will include 3 groups of people, people with normal blood pressure, people with high blood pressure and people with kidney disease. - Subjects will have a screening physical examination, including an ECG and laboratory tests - Subjects with high blood pressure may not take their regular blood pressure medication for 3 weeks prior to the inpatient GCRC study - Subjects will be given intra-arterial medications that will cause changes in the blood vessels during the in-patient study. The study will then compare the responses of the three groups. A GFR test will be done to confirm the renal function of the group with chronic kidney disease. These studies will provide insight into the mechanisms of the pathogenesis of enhanced α1 vasoreactivity in subjects with progressive renal disease. This will lay the groundwork for new strategies in the treatment and prevention of vascular disease among the rapidly growing group of individuals with CKD.

NCT ID: NCT00353574 Terminated - Hypertension Clinical Trials

DORADO-EX: Long-Term Safety Extension Study to the Phase 3 DORADO Study (Protocol DAR-311) of Darusentan in Resistant Hypertension

Darusentan
Start date: September 2006
Phase: Phase 3
Study type: Interventional

This is a research study of a new experimental drug called darusentan. Darusentan is not currently approved by the United States (U.S.) Food and Drug Administration (FDA) for use in the U.S., which means that a doctor cannot prescribe this drug. The purpose of this study is to evaluate the long-term safety of darusentan in subjects with resistant systolic hypertension despite treatment with full doses of three or more antihypertensive medications, including a diuretic.

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: NCT00329862 Terminated - Hypertension Clinical Trials

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Start date: May 2006
Phase: N/A
Study type: Interventional

Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves to the stomach) will produce greater weight loss and better reduction of co-morbidities (diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be enrolled and outcomes compared to LAGB historical controls over a post-operative period of 24 months.

NCT ID: NCT00327080 Terminated - HIV Clinical Trials

Sildenafil to Treat HIV-Associated Pulmonary Hypertension

Start date: May 12, 2006
Phase: Phase 1
Study type: Interventional

This study will examine how blood pressure in the lungs is controlled in healthy people, people with HIV and people with HIV and pulmonary artery hypertension (high blood pressure in the lungs, also called PAH). PAH sometimes develops in people with HIV, but it is not known why this occurs or how best to treat it. Healthy volunteers and patients with HIV infection who are 18 years of age or older may be eligible for this study. All candidates are screened with a medical history, physical examination, electrocardiogram (EKG), chest x-ray, echocardiogram and blood tests. Participants undergo the following procedures: All participants have a right heart catheterization and forearm blood flow study. - Catheterization study. A catheter (plastic tube) is placed in an arm vein and possibly in an artery in the arm. Then a large catheter is passed through a vein in the groin, neck or chest. Through this "introducer" catheter, another catheter is advanced into the right side of the heart and to the pulmonary artery. A facemask is put in place to measure the amount of nitric oxide produced by the lungs. Acetylcholine is infused through the catheter and its effects on blood pressure in the lungs and on the amount of nitric oxide exhaled is measured. After about 1 hour, the catheter and facemask are removed and a new catheter is inserted through the introducer catheter into the pulmonary artery. The subject is moved into an MRI scanner where blood flow is measured after infusion of three different medications: acetylcholine (causes blood vessels to expand and slows heart rate); sodium nitroprusside (causes blood vessels to expand and increases blood flow to the heart); and L-NMMA (decreases blood flow by blocking production of nitric oxide in cells lining the blood vessels). - Blood flow study. Small tubes are inserted into the artery of the patient's forearm. These are used to infuse medicines and draw blood samples. Forearm blood flow is measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood flows into the arm, stretching the strain gauge, and the flow measurement is recorded. A small lamp is positioned over the hand to measure the light reflected from the hand and blood flow in the forearm. Blood samples are then drawn to measure blood counts and proteins and other natural body chemicals. Then, forearm blood flow is measured after administration of small doses of sodium nitroprusside, acetylcholine and L-NMMA. There is a 20- to 30-minute rest period between injections of the different drugs. In addition, HIV-infected patients with PAH undergo the following tests to determine the cause of their PAH: CT scan of the lungs, pulmonary function tests, 6-minute walk test, quality-of-life assessment, assessment of difficulty in breathing, exercise testing while measuring oxygen breathed in and carbon dioxide breathed out, blood tests, monitoring of oxygen saturation during sleep for 1 night and ventilation/perfusion scan. For the ventilation/perfusion scan, the subject breathes in a small amount of radioactive aerosol while images are obtained of the radioactivity as it enters the lungs, and then pictures of the lungs are taken from multiple angles. Next, the patient receives an injection of tiny particles of albumin (a protein) containing a small amount of radioactivity and pictures of the lungs are taken that show the pattern of blood flow to the lungs. Patients with HIV and PAH who may benefit from the investigational drug, sildenafil (commonly known as Viagra), may continue to participate in the next stage of the study. They receive the first dose of sildenafil after completing the forearm blood flow study. They continue the drug for 16 weeks, returning to the clinic 1 week after the first dose and then every other week to monitor the response to treatment and drug side effects. At the end of 16 weeks, patients return to the clinic for a repeat evaluation, including blood tests, 6-minute walk test, echocardiogram, right heart catheterization and forearm blood flow study. ...

NCT ID: NCT00322725 Terminated - Cancer Clinical Trials

Bevacizumab (Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review

Start date: February 2006
Phase:
Study type: Observational

1.11 Retrospectively evaluate for a correlation between tumor response and changes in systolic/diastolic/mean arterial blood pressures in patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies. 1.12 Retrospectively evaluate for differences in tumor response between patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies. 1.21 Determine if there were differences in bevacizumab induced hypertension rates between different tumor types. 1.22 Evaluate for differences in bevacizumab induced hypertension rates between males and females. 1.23 Examine if there were associations between a particular chemotherapeutic agent(s), that may have had an increased propensity of inducing hypertension when combined with bevacizumab.

NCT ID: NCT00313547 Terminated - Hypertension Clinical Trials

High-Dose Quinapril Versus Low-Dose Quinapril Plus Amlodipine in the Treatment of High-Risk Hypertensive Patients

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

The purpose of this study is to compare the impact of two blood pressure lowering treatments (high dose quinapril versus low dose quinapril plus amlodipine) on variations in heart rate over 24 hours.

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.