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Pulmonary Hypertension clinical trials

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NCT ID: NCT01950585 Withdrawn - Clinical trials for Pulmonary Hypertension

Hydroxyurea in Pulmonary Arterial Hypertension

Start date: September 6, 2013
Phase: Early Phase 1
Study type: Interventional

Pulmonary arterial hypertension (PAH) is a serious and eventually fatal disease damaging the lungs and the heart. It results from narrowing and eventual blockage of small blood vessels in the lung, due to abnormal proliferation of cells in the blood vessel (arterial). Patients with PAH suffer from fatigue, shortness of breath, low oxygen levels, blood clots and heart failure. No therapies reverse the disease process in the lung arteries, however there are three approved drugs that can temporarily dilate the vessels and improve symptoms. However, all three drugs have significant side effects and toxicities, they do not work effectively in many patients, survival remains on average only 2 to 3 years once symptoms begin, and none of these drugs prevent the underlying disease process in the small arteries of the lung. PAH is known to develop in patients with a pre-existing class of bone marrow diseases called myeloproliferative disorders (MPDs). We and others have recently shown that patients with PAH have bone marrow changes similar to those seen in patients with MPDs, even without other signs and symptoms of those bone marrow diseases such as anemia or high platelet and white blood cell counts. Compared to healthy volunteers, patients with PAH have a higher frequency of immature stem and progenitor cells able to produce blood cells and vascular wall cells in their bone marrow. They also have higher circulating numbers of these cells in the blood, and increased localization of these cells in the lung blood vessels. When immature bone marrow cells from PAH patients and normal volunteers were infused into mice, the mice receiving PAH marrow cells developed similar lung and heart problems to PAH patients, suggesting that the bone marrow problem is a primary cause of the lung problems, and that the increased numbers of immature bone marrow cells in the bone marrow and blood of PAH patients causes the lung blood vessel disease. The drug hydroxyurea is used to inhibit the abnormally high level of bone marrow cell proliferation in patients with MPDs. It has been shown to reduce the numbers of circulating immature bone marrow cells in patients with MPDs. Hydroxyurea has been available for almost fifty years, and has been used to treat patients with MPDs, sickle cell anemia, and congenital heart disease for very prolonged periods of time, up to twenty or more years in individual patients. It has an excellent long-term safety profile and few side effects and is generally well tolerated. It does not appear to result in an increased rate of leukemia even with many years of treatment. In the current protocol, we hypothesize that treating patients with PAH with hydroxyurea will decrease the level of circulating immature bone marrow cells and interrupt the abnormal narrowing and occlusion of lung arteries. We will treat patients with moderately severe primary (no known underlying cause) PAH with 6 months of hydroxyurea, carefully monitoring side effects and adjusting dosage as necessary, and measure the effect on circulating immature cells, lung blood vessel pressures, other blood markers of active PAH, and exercise tolerance.

NCT ID: NCT01948518 Completed - Clinical trials for Pulmonary Hypertension

Effect of Sildenafil on Diffusion Capacity in Patients With PH and Parenchymal Lung Disease

Start date: June 2009
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the acute effects of sildenafil on diffusion capacity, a commonly performed pulmonary function test, which is used to assess the lungs' gas exchange capability. This study does not assess safety or efficacy of the drug. The study does not have clinical end points. The variables studied are diffusion capacity and 6 minute walk after a single dose of sildenafil. This study has been completed.

NCT ID: NCT01932606 Completed - Clinical trials for Pulmonary Hypertension

Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

Start date: August 2013
Phase: Phase 2
Study type: Interventional

Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. This study assessed the effects of acute nitrite administration on resting and exercise hemodynamics in patients with HFpEF.

NCT ID: NCT01917136 Completed - Clinical trials for Pulmonary Hypertension

11C-acetate/18Fluorodeoxyglucose-FDG PET/CT and Cardiac MRI in Pulmonary Hypertension

Start date: August 2013
Phase: Phase 2
Study type: Interventional

This study is looking at differences in metabolism and functional imaging between pulmonary hypertension subjects with normal right ventricular function and persistent right ventricular dysfunction.

NCT ID: NCT01913847 Recruiting - Clinical trials for Pulmonary Hypertension

Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.

NCT ID: NCT01913457 Terminated - Clinical trials for Pulmonary Hypertension

Measurements and Characterization of Doppler Signals From the Right Chest in Pediatric and Adult Patients

Start date: July 2013
Phase:
Study type: Observational [Patient Registry]

Recently it has been shown that clear reproducible Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package parametric Doppler, TPD, EchoSense Ltd., Haifa, Israel). These lung Doppler signals (LDS) are in full synchrony with the cardiac cycle and can be obtained from the lungs, including areas remote from the heart and main pulmonary vessels. The LDS waves typically have peak velocities of up to 30 cm/s and are of relatively high power, making it possible to detect them despite the aforementioned attenuation by the air in the lungs. The LDS are thought to represent the radial wall movement of small pulmonary blood vessels, caused by pressure pulse waves of cardiac origin which propagate throughout the lung vasculature. The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio-vascular system in general. Pulmonary arterial hypertension (PAH) is a condition characterized by reshaping of the small pulmonary arteries with increase in pulmonary vascular resistance, leading gradually to right-sided cardiac failure. A trans-thoracic echocardiograph (TTE) is a test classically undertaken in order to screen for pulmonary hypertension. However, the systolic pulmonary artery pressure (SPAP) values thereby obtained are often imprecise and depend upon the expertise of the individual carrying out the test. Therefore, the pulmonary arterial pressure and cardiac output values have to be ascertained with a right-sided cardiac catheterization, which is considered the gold-standard, but is invasive. In a pilot study of adult PAH patients (unpublished), lung Doppler signals have been shown to have the potential to diagnose pulmonary hypertension in two different ways: First, by measuring the degree of attenuation of the LDS during acute pressure rise in the chest cavity (i.e. during Valsalva maneuver). Second, by detecting differences between the LDS in patients with PAH and control subjects. One of the objectives of the present study is to evaluate the lung Doppler signals in pediatric patients of various age groups, with and without pulmonary vascular disease. The second objective of the study is to verify previous findings of abnormal lung Doppler signals in adult patients with pulmonary hypertension.

NCT ID: NCT01910389 Terminated - Heart Failure Clinical Trials

Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure

PITCH-HF
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) <0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

NCT ID: NCT01894035 Completed - Clinical trials for Pulmonary Hypertension

Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation

COMPHI
Start date: September 23, 2013
Phase:
Study type: Observational

This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation). The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months. The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013. Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.

NCT ID: NCT01884974 Recruiting - Clinical trials for Pulmonary Hypertension

A Case Control Study of the Prevalence of Pulmonary Hypertension in Patients With Myeloproliferative Diseases.

PH-MPD1
Start date: July 2013
Phase: N/A
Study type: Observational

Pulmonary hypertension (PH) is defined as a group of diseases characterised by an elevated mean pulmonary artery pressure (Ppa) ≥25 mmHg at rest. Recently, chronic myeloproliferative diseases (CMPD) associated with pulmonary hypertension were included in the group 5 category, corresponding to PH for which the aetiology is unclear and/or multifactorial. CMPD include chronic myelogenous leukaemia, chronic neutrophilic leukaemia and chronic eosinophilic leukaemia (which primarily express a myeloid phenotype and polycythaemia vera), idiopathic myelofibrosis, and essential thrombocytosis in which erythroid or megakaryocytic hyperplasia predominates. The purpose of this research: 1. Assess Prevalence of PH in patients with CMPD in Northern Israel 2. Describe the demographics and clinical course in patients with CMPD who are diagnosed with PH.

NCT ID: NCT01862536 Completed - Clinical trials for Pulmonary Hypertension

Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

TADA-PHILD
Start date: October 1, 2013
Phase: Phase 2
Study type: Interventional

The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare system parallels these findings. According to the VA HSR&D Health Economics Resource Center, COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran patient population, is responsible for >14,000 VA hospital admission annually, and increases by $1,051/patient the total annual health care cost burden on the VA Healthcare system. Importantly, COPD is associated with frequent emergency room visitation and/or hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen morbidity and mortality in patients with COPD. This study will examine the potential for tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by decreasing pulmonary hypertension. Results from this study are expected to define the potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this treatment option may improve quality of life and outcomes for the large number of Veterans afflicted with PH due to COPD.