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Pulmonary Hypertension clinical trials

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NCT ID: NCT03542812 Terminated - Clinical trials for Pulmonary Hypertension

L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia

Start date: July 30, 2019
Phase: Early Phase 1
Study type: Interventional

Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects up to 35% of very low birth weight infants (VLBW < 1500 g). Based on the current numbers of VLBW infants born annually in the U.S., between 5,000-10,000 neonates will develop BPD each year. It is estimated that 8-42% of infants with BPD will develop pulmonary hypertension (PH). Moreover, it has been known since the 1980's that echocardiographic evidence of PH in infants with BPD is associated with up to 40% mortality. Treatment options to ameliorate PH in infants with BPD (BPD-PH) are limited. There have been no randomized clinical trials of any therapy in infants with BPD-PH. The standard care for the management of BPD-PH is to attempt to resolve the underlying lung disorder and the judicious use of oxygen as a potent pulmonary vasodilator. Using this management approach, which has not changed since the 1980's, the survival rates for infants with BPD-PH in the 2000's has been reported to be 64% at 6 months and 53% at 2 years after diagnosis of PH. The lack of improvement in outcomes for the past 3 decades has led to the widespread agreement that novel and effective therapies are desperately needed for infants with BPD-PH. The goal is to develop oral L-citrulline clinically for the treatment of pediatric pulmonary hypertension associated with bronchopulmonary dysplasia (BPD-PH); before pursuing a large scale treatment trial, pharmacokinetic (PK) dose-finding, tolerability studies in patients at high risk of developing BPD-PH are warranted. The hypothesis is that oral L-citrulline will be well tolerated, without significant adverse effects in infants at high risk of developing pulmonary hypertension (PH) associated with BPD. The investigators propose to first characterize the PK profile of oral L-citrulline in order to define an appropriate dose range and treatment interval for infants at high risk of developing BPD-PH. Then using the doses and intervals generated by the PK profile, with a maximum dose of 3 g/kg/d, the investigators propose to evaluate the tolerability and ability to achieve the target study drug level (100-150 micromolar) in babies treated for 72 hours with oral L-citrulline. These studies will provide the data needed to design a full-scale randomized multi-center trial to evaluate the efficacy of oral L-citrulline therapy to ameliorate BPD-PH in human infants, a patient population that has a desperate need of new therapies.

NCT ID: NCT03496623 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

A Phase 3 Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Participants With Pulmonary Hypertension (PH) Due to Chronic Obstructive Pulmonary Disease (COPD)

PERFECT
Start date: May 8, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy of inhaled treprostinil compared to placebo in improving exercise ability as measured by change from baseline in 6-Minute Walk Distance (6MWD) following 12 weeks of active treatment in participants with PH-COPD.

NCT ID: NCT03476629 Recruiting - Clinical trials for Cardiovascular Diseases

Effects of Different Types of Physical Training in Patients With Pulmonary Arterial Hypertension.

PAH
Start date: January 10, 2016
Phase: N/A
Study type: Interventional

Although there has been some progress in pharmacological management of PAH, limited functional capacity and low survival still persist, but there is evidence that exercise training can be accomplished without adverse effects or damage to cardiac function and pulmonary hemodynamics. Specifically, improvements in symptoms, exercise capacity, peripheral muscle function and quality of life. Training programs need to be better studied and well defined, and their physiological effects during physical training and functional capacity. The aim of this study is to compare the effects of different training exercises on physical performance indicators.

NCT ID: NCT03464591 Recruiting - Clinical trials for Pulmonary Hypertension

Cardiac Speckle Tracking Myocardial Strain Balance

Start date: November 1, 2017
Phase:
Study type: Observational

The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.

NCT ID: NCT03460470 Recruiting - Heart Failure Clinical Trials

Sildenafil in US Heart Failure Patients (SilHF-US)

SilHF-US
Start date: February 14, 2018
Phase: Phase 3
Study type: Interventional

This protocol describes a 2-arm randomized controlled pilot study assessing the tolerance, safety and efficacy of sildenafil compared to control. The hypothesis is that sildenafil will be well tolerated and efficacious in patients with chronic heart failure (NYHA class II and III) with evidence of systolic dysfunction (EF ≤40 %) and secondary pulmonary hypertension (SPAP >40mmHg). Patients that satisfy the inclusion criteria will be randomized to sildenafil (40mg x 3) or placebo therapy for 6 months in a 2:1 blinded fashion. The placebo group will be compared to the active therapy group and analyzed for differences in the main study end-points Patient Global Assessment and 6-Minute Walk Test. The study will also assess safety, tolerability, symptoms and quality of life.

NCT ID: NCT03459716 Recruiting - Clinical trials for Pulmonary Hypertension

Endothelial Biomarkers of Systemic Sclerosis-associated Pulmonary Hypertension

BOSS-PH
Start date: June 1, 2018
Phase:
Study type: Observational

Systemic sclerosis (SSc, AKA scleroderma) is an autoimmune condition characterized by endothelial damage and progressive fibrosis of the skin and internal organs. One of the leading causes of morbidity and mortality in patients with SSc is pulmonary hypertension (PH), which is estimated to occur in up to 31% of high risk SSc patients. Early detection of patients with SSc-PH may lead to improved outcomes and although there have been concerted efforts to accurately screen for SSc-PH, these patients continue to present with advanced disease and suffer from poor survival. Therefore, better methods to screen for patients with PH and, perhaps more importantly, to screen for those at risk for PH development are desperately needed. Since PH and SSc are disorders originating from the endothelium, biomarkers that reflect endothelial damage are very promising tools to identify early disease. Such potential biomarkers include endothelial microparticles, asymmetric dimethylarginine (ADMA), pentraxin-3, and soluble endoglin. No previous study has used a combination of these biomarkers to detect the presence of PH in patients with SSc, or studied the novel concept of exercise-induced changes in biomarker levels. The investigators will collect the above listed endothelial biomarkers before and after exercise, and combine these levels with exercise echocardiogram findings, and routine clinical information to derive a composite detection score for the early identification of systemic sclerosis-associated PH.

NCT ID: NCT03438123 Completed - Parkinson Disease Clinical Trials

Data Collection Study for the Spectrum Dynamics Multi-purpose CZT SPECT Camera

Start date: November 28, 2017
Phase: N/A
Study type: Interventional

This study evaluates SPECT image data acquired from Spectrum Dynamics' multi-purpose CZT SPECT-CT camera. All subjects will undergo routine clinical Anger SPECT imaging and an additional SPECT acquisition on the CZT SPECT camera. Additionally some subjects will undergo CT on the CZT SPECT-CT camera. The quality of images from each device will be compared.

NCT ID: NCT03404492 Completed - Clinical trials for Pulmonary Hypertension

Effects of Cardiorespiratory Rehabilitation on the Right Ventricle in Pulmonary Hypertension

Rehab-HTP
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

Clinical improvement has been demonstrated after cardiorespiratory rehabilitation in patients with pulmonary hypertension. Rehabilitation is therefore now part of the recommendations for good practice. However, no data is available to elucidate the mechanism of this improvement: an improvement in myocardial reserve or an improvement in peripheral muscular capacity? The main objective of this study is to evaluate the difference in right ventricular contractile reserve before and after cardiorespiratory rehabilitation during stress ultrasound in pulmonary hypertension in 10 patients with pulmonary hypertension.

NCT ID: NCT03396120 Completed - Clinical trials for Pulmonary Hypertension

The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease

Start date: February 2, 2017
Phase: N/A
Study type: Observational

Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes. Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.

NCT ID: NCT03385733 Completed - Clinical trials for Pulmonary Hypertension

Inspiratory Muscle Training in Pulmonary Hypertension

Start date: October 10, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effective of inspiratory muscle training on respiratory function, exercise capacity, physical activity and quality of life.