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Pulmonary arterial hypertension is a common, persistent disease that affects the small pulmonary arteries. The aim of this clinical investigation is to determine the safety profile of the Model 10642 Implantable Intravascular Catheter portion of the PAH Implantable Vasodilator Therapy device's Implantable Vasodilator Therapy device. This report will examine the reliability of Remodulin Injection delivery in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved product, and the approved intravenous route of administration. The Model 10642 Catheter tube is different from other commercially available drug delivery catheters because it has a one-way valve that allows the medication to flow out but prevent the blood from flowing back into the catheter tube. Remodulin Injection is a Food and Drug Administration approved drug for intravenous and subcutaneous treatment of PAH. The use of x-ray imaging has also been used to determine the shape of the Model 10642 Implantable Intravascular Catheter during a set of patient positions. Up to seven centers will be participating in the Delvivery for PAH clinical trial, with at least three months post-implant of their latest catheter and pump.
Source link: https://clinicaltrials.gov/ct2/show/NCT01321073
Patients with pulmonary arterial hypertension have reduced quality of life and reduced exercise capacity. The Investigators will randomly assign 100 PAH patients to either the mHealth treatment or standard care. Using the PAH-specific emPHasis-10 questionnaire, the Investigators will examine the effect of a text-based mHealth intervention in PAH on HRQOL. The Investigators will also determine the effects of an mHealth intervention on exercise capacity, as shown by a controlled home-based 6MWD test. The Investigators will investigate the effects of the intervention on time to clinical deterioration one year after randomization.
Source link: https://clinicaltrials.gov/ct2/show/NCT05464095
According to the WHO classification system, A Phase III, randomized, open label, pragmatic trial to compare the safety and effectiveness of first-line combination therapy to first-line monotherapy in pediatric patients with WHO Functional Classes II or III and precapillary pulmonary hypertension of Group 1 or Group 3 respectively. Precapillary hypertension, pulmonary artery pressure over 25 mmHg and/or pulmonary vascular resistance index > 3, as well as pulmonary capillary wedge pressures > 25 mmHg as determined by cardiac catheterization, will be defined by standard criteria as mean pulmonary arterial pressure over 25 mmHg and/or pulmonary vascular resistance index > 3. The investigators also intend to obtain blood, swab, and urine samples to see whether inherent genetic variations or novel proteomic biomarkers can be associated with clinical responsiveness to interventions within the cohort. Bio-specimens will be collected to see if therapeutic responders will have a different genomic or proteomic profile as compared to patients who do not respond well to therapy. Combination therapy is a safe treatment option for pediatric patients with PAH because sildenafil and bosentan have different mechanisms of action targeting different intracellular pathways. Combination therapy with longer duration agents with the same principles of action, according to previous studies in adult PAH, may result in greater and sustained improvement in clinical course in comparison to monotherapy. It's unclear if children with pneumonia respond and tolerate combination therapy better than monotherapy.
Source link: https://clinicaltrials.gov/ct2/show/NCT04039464
In-human PET imaging of 18F-fluoroglutamine in patients with PAH will be used to compare glutamine uptake to that of controls. Human subjects: Given the fact that this tracer for human use has already been approved, the testing process to begin human testing should be carried out in a fast fashion. Investigators do not anticipate difficulties in recruiting idiopathic PAH patients, anchored by Dr. Chan's experience in such research, given our track record for high-volume patient recruitment for PAH clinical studies. Women of child-bearing age will need to pass a urine pregnancy test on the day of the scan session prior to any PET scan procedures. The axial extent of the heart and the majority of lung tissue will be determined by a scout CT scan to position the PET bed so that the superior axial image planes are about 1 cm above the lung apex. During a 15 sec inspiratory breath hold and used for CT-based attenuation correction of PET emission results and as an anatomical reference for image analysis, a low-dose helical CT scan will be performed. Blood Sampling: The PET scan will get blood samples from hand-drawn arterial blood samples throughout the scan, with no more than 20 collected during the first 2 min and no more than 15 collected at intervals of increasing duration minutes. If for reasons of participant phobia or technical difficulties, the full PET scanning procedure cannot be carried out in one day investigators may not be completed in a single day, investigators may be asked to return within 30 days to complete the investigation. Following-up Procedures: A follow-up telephone call will be sent to participants by the PET/CT scan to ask about any adverse events related to the scans. Investigators will request subjects to access medical records relating to their health condition that has been embedded in the Research study. The medical record information contained within the study database will continue to be used for study-related activities for an indefinite period.
Source link: https://clinicaltrials.gov/ct2/show/NCT05452889
Pulmonary arterial hypertension is a condition in which the blood pressure in the pulmonary arteries is elevated. The severity of baseline PAH is correlated with the development of major illnesses, such as the fact that people with elevated PAP levels than their systemic blood pressure had an 8fold greater risk of complications. Sadly, there are no studies and no consensus in the pediatric literature on how the PH epidemic should be handled. Over the past ten years we have gained extensive experience in dealing with children with PAH and preventing and treating their acute cases by using phenylephrine, a drug. This drug is used to elevate the blood pressure in patients to treat hypotension. We're hoping that by raising SBP, we'll expand the blood flow to the coronary arteries and prevent the right ventricle from failing acutely.
Source link: https://clinicaltrials.gov/ct2/show/NCT05439460
1 Define the relationships between RV steatosis, RV function, and exercise capacity; 2 Identify mechanistic factors of RV steatosis, including BMPR2 expression and lipid metabolism; 3 Examine lipid metabolism in PAH skeletal muscle as a potential source of reduced functional capacity. The investigators will perform MRS on skeletal muscle in Aim 1 participants and healthy controls to determine the systemic effects of lipid metabolic abnormalities in PAH, with Aim 3 specificity.
Source link: https://clinicaltrials.gov/ct2/show/NCT05462574
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