Prospective Validation of the Novel PVD-B65 Risk Score in Patients With Chronic Lung Disease and Pulmonary Hypertension
NCT07151768 · Chronic Lung Disease,
Pulmonary Hypertension RecruitingProspective observational study to determine if the PVD-B65 risk score for one-year mortality in patients with chronic lung disease and pulmonary hypertension (CLD-PH) can accurately risk stratify these patients and successfully predict one-year mortality from time of pulmonary hypertension diagnosis. PVD-B65 risk score was developed in a retrospective cohort of patients with CLD-PH, utilizing the presence of pulmonary fibrosis without emphysema, pulmonary vascular resistance (PVR) \> 5 woods units (WU), 6-minute walk distance (6MWD) \< 150 meters, B-natriuretic type peptide (BNP) \> 200 pg/mL or N-terminal pro-natriuretic type peptide (NT-proBNP) \> 300 pg/dL, and age \> 65 years as the score components.
Phase—
TypeObservational
Age18 Years – 99 Years
WherePhiladelphia, Pennsylvania, United States
SponsorTemple University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)
NCT06826859 · Preterm Birth, Preeclampsia
RecruitingAspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.
PhasePhase 1 / Phase 2
TypeInterventional
Age16 Years – 55 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Path to Optimal Black Maternal Heart Health: Comparing Two CVD Risk Reduction Interventions (Change of HEART)
NCT05499507 · Pregnancy Related,
Hypertension, Obesity
RecruitingThe overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
PhaseNA
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorTemple University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.
Phase—
TypeObservational
Age1 Day – 21 Years
WherePalo Alto, California, United States + 13 more
SponsorNew York Medical College
▾Tap for detailsClick for full details — eligibility, all locations, contacts DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
RecruitingThis is a prospective, real world, multicenter, registry of patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) and interstitial lung disease (ILD).
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 66 more
SponsorUnited Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY)
RecruitingThis study evaluates the effect of ROC-101 in adults with either Pulmonary Arterial Hypertension (PAH) or Pulmonary Hypertension Associated with Interstitial Lung Disease (ILD-PH). Each eligible participant will receive standard of care (SOC) plus ROC-101 for a 24-week treatment period, followed by a long-term extension period of the study through the end of the program or marketing approval/authorization.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 18 more
SponsorAllRock Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clarifying the Optimal Application of SLT Therapy Trial
RecruitingThe goal of this study is to understand if SLT performed at low energy is as effective as SLT performed at standard energy, and also to see if repeating SLT at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for SLT to wear off before repeating it.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLaguna Hills, California, United States + 28 more
SponsorUniversity of Pittsburgh
▾Tap for detailsClick for full details — eligibility, all locations, contacts Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
RecruitingA multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
PhaseNA
TypeInterventional
Age18 Years
WhereNew York, New York, United States + 2 more
SponsorJennifer Lewey, MD, MPH
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07179380 ·
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingThe primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 108 more
SponsorInsmed Incorporated
▾Tap for detailsClick for full details — eligibility, all locations, contacts iTONE Trial (exercIse Training in pulmONary hypertEnsion) Exercise Program for Pediatric PH
RecruitingChildren with pulmonary hypertension (PH) engage in less physical activity than their peers. This is a concern since adult data support exercise as a non-pharmacologic treatment for PH. Despite adult data, therapeutic exercise has not been widely adopted in pediatric PH. Investigators have previously demonstrated that children with PH have less skeletal muscle mass in association with worse exercise performance. Interventions to increase physical activity and skeletal muscle mass may improve exercise performance and quality of life in children with PH. This study will use wearable activity monitoring devices to promote physical activity in a 16-week pilot intervention in children and teenager with PH.
PhaseNA
TypeInterventional
Age8 Years – 18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorChildren's Hospital of Philadelphia
▾Tap for detailsClick for full details — eligibility, all locations, contacts Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
RecruitingPatients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH. Subjects will be asked to attend a baseline visit where the following will be performed: * Measure your vital signs * Undergo a research blood draw, less than 4 tablespoons * Provide a urine pregnancy test (if applicable) * Review demographics, personal history, and medical history * Review current PAH medications * Complete questionnaires on how your PAH affects you * Complete a test of physical performance * Complete a grip strength test * Undergo an echocardiogram (Echo) * Complete a six-minute walk test * Undergo a Chest CT Scan * Undergo a scan of your body composition (DXA scan) * Obtain a weight and body composition measurement on the InBody Scale Subjects will also complete activity moniotring, two 24-hour diet recalls, and participate in remote follow-up visits every 6 months
PhaseNA
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorUniversity of Pennsylvania
▾Tap for detailsClick for full details — eligibility, all locations, contacts Non-Invasive Preeclampsia Screening and Biobank
NCT06643741 · Preeclampsia (PE)
RecruitingWomen pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.
Phase—
TypeObservational
Age18 Years
WhereGlendale, Arizona, United States + 20 more
SponsorSequenom, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
NCT03487185 · Obstructive Sleep Apnea of Adult, Preeclampsia, Obstetrical Complications
RecruitingA randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 13 more
SponsorThe George Washington University Biostatistics Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
NCT07220876 · Open Angle Glaucoma (OAG)
RecruitingA Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
PhaseNA
TypeInterventional
Age45 Years
WhereGlendale, Arizona, United States + 11 more
SponsorAvisi Technologies Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts SHAPE of Portal Hypertension in Children
RecruitingEarly diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.
PhasePhase 2
TypeInterventional
Age6 Years – 21 Years
WherePhiladelphia, Pennsylvania, United States
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Caffeine Consumption in Glaucoma Patients and Healthy Subjects
NCT03675412 · Glaucoma, Primary Open Angle
RecruitingCaffeine is the most widely consumed drinking nutrient in the world. Caffeine effects various organs and the vascular system. It decreases ocular blood flow due to vasoconstriction.
PhaseNA
TypeInterventional
Age18 Years – 90 Years
WherePhiladelphia, Pennsylvania, United States
SponsorWills Eye
▾Tap for detailsClick for full details — eligibility, all locations, contacts Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal
NCT05470205 · Liver Diseases,
Portal Hypertension RecruitingThis is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using different ultrasound contrast agents (Definity \[Lantheus Medical Imaging, N Bilerica, MA, USA\] and Sonazoid \[GE Healthcare, Oslo, Norway\] in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the reproducibility of the SHAPE algorithm. Cohort 2: Patients identified as having clinically significant portal hypertension (CSPH) will be monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average). These subjects will have follow-up ultrasound scans every 6 ± 2 months to check for hepatocellular carcinoma (HCC) (using the Barcelona-Liver Cancer staging system) as well as ascites and at those times a repeat SHAPE examination will be performed. Liver stiffness values will be measured with elastography as well. This cohort will examine if serial SHAPE can accurately predict development of ascites and other liver related events in patients with compensated cirrhosis undergoing routine HCC surveillance in a multi-center setting. Cohort 3: Subjects newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE and results compared to elastography measurements of liver stiffness with standard assessments (e.g., serum liver function tests and measurement of spleen size as well as platelet count). This cohort will establish if SHAPE can be used to monitor treatment response in patients identified with portal hypertension. Cohort 4: Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices relative to the Baveno VI and the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index will undergo a SHAPE examination. This cohort will compare the predictive ability of SHAPE for allocating patients with compensated advanced chronic liver disease to screening of varices compared to the current standard of care.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States + 2 more
SponsorThomas Jefferson University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sleep Promotion and Pediatric Hypertension
NCT06642246 · Insufficient Sleep,
Hypertension RecruitingDetermine the effectiveness and feasibility of a mobile health sleep extension approach in the pediatric nephrology setting, to increase sleep duration and reduce systolic and diastolic blood pressure.
PhaseNA
TypeInterventional
Age13 Years – 18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorChildren's Hospital of Philadelphia
▾Tap for detailsClick for full details — eligibility, all locations, contacts Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma
NCT07228221 · Open Angle Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma
RecruitingThe Investigators will investigate the efficacy of combining the standalone iStent infinite and iDose that are minimally invasive surgical and drug depot options are a safe and effective alternative to filtering surgery for intraocuar pressure reduction in patients with medically uncontrolled open angle glaucoma.
PhasePhase 4
TypeInterventional
Age18 Years
WherePhiladelphia, Pennsylvania, United States
SponsorJonathon Myers
▾Tap for detailsClick for full details — eligibility, all locations, contacts BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT
RecruitingA prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra/Azure pacemaker.
PhaseNA
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 130 more
SponsorOrchestra BioMed, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts