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Showing 1-20 of 1,685 trials
NCT04691154
This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of L606 in patients with PAH or PH-ILD. The study will determine the short-term and long-term safety and tolerability of L606 in this patient population.
NCT00098072
This study will examine and test healthy volunteers and patients with pulmonary hypertension to try to learn more about the disease and find better ways to detect, treat, and, if possible, slow progression. Pulmonary hypertension is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels and may become life-threatening. Normal volunteers and patients with pulmonary hypertension 18 years of age and older may be eligible for this study. All candidates are screened with a review of their medical records. Normal volunteers also have a medical history, electrocardiogram, echocardiogram (heart ultrasound), and pulmonary function test, in which the subject breathes in and out of a tube that measures lung volume, mechanics and function. All participants undergo the following tests and procedures: * Echocardiogram to measure heart function and blood pressure in the lungs. A small probe held against the chest uses sound waves to obtain pictures of the heart. * Magnetic resonance imaging (MRI) to evaluate the heart's pumping action. Subjects lie on a stretcher that slides into a long, tube-shaped scanner. The machine uses a magnetic field and radio waves to obtain images of the heart. * 6-minute walk to measure how far the subject can walk in 6 minutes. Subjects walk around the hospital for 6 minutes at a comfortable pace. * Exercise testing to measure the ability to exercise and the subject's oxygen levels during exercise. Subjects exercise on a bike or treadmill while the oxygen and carbon dioxide they breathe are measured using a small device placed in the mouth. * Right heart catheterization to measure pressure in the heart and lungs. A small catheter (plastic tube) is placed in an arm vein. A longer catheter called a central line is placed in a deeper vein in the neck or just below the neck, or in the leg or arm. A long, thin catheter that measures blood pressure directly is then inserted into the vein and advanced through the chambers of the heart into the lung artery to measure all the pressures in the heart and obtain blood samples. * Genetic and protein studies. DNA, RNA, and proteins from blood samples are studied for genes and proteins that might predict the development or progression of pulmonary hypertension. In addition to the above, patients whose pulmonary hypertension was caused by a blood vessel injury undergo the tests described below. The right heart catheter inserted for the catheterization procedure remains in place to obtain measurements of the effects of nitric oxide and nitrite in the following procedures: * Inhalation of nitric oxide (a gas naturally produced by cells lining arteries) at 30-minute intervals to examine its effect on lung and heart pressures. * Inhalation of aerosolized nitrite at 5-minute intervals to measure its effects on lung and heart pressures. * Inhalation of nitric oxide for up to 24 hours to obtain multiple measurements of its effect on lung and heart pressures. * Blood draws for laboratory tests. In patients whose pulmonary hypertension was caused by a blood vessel injury, we also plan to follow response to standard therapy. After the initiation of standard therapy, we will restudy the same parameters (excluding NO and sodium nitrite studies) in these patients at approximately 4 months, and yearly for 5 years ...
NCT02417740
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH. Objectives: \- To learn more about how NCPH develops over time. Eligibility: \- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse. Design: * Participants will have 2 screening visits. * Visit 1: to see if they have or may develop NCPH. * Medical history * Physical exam * Urine and stool studies * Abdominal ultrasound * Fibroscan. Sound waves measure liver stiffness. \<TAB\>- Visit 2: * Blood tests * Abdominal MRI * Echocardiogram * Questionnaire * Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein. * They may have a liver biopsy. * All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly. * Participants with NCPH will also have: * Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach. * At least every 2 years: Esophagogastroduodenoscopy. * At least every 4 years: testing including HVPG measurements and liver biopsy. * Participants without NCPH will also have: * Liver biopsy and HVPG measurements to see if they have NCPH. * Every 2 years: abdominal MRI and stool studies. * The study will last indefinitely.
NCT07483372
This is a single-center, open-label, exploratory clinical study designed to evaluate the safety and efficacy of a single-session injection of SC101, a small interfering RNA (siRNA) agent, into the perirenal fat. This study plans to enroll 3 participants, aged 18 to 65 years, who have a clinical diagnosis of resistant hypertension and moderate to severe chronic kidney disease (CKD).
NCT07481981
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.
NCT05236725
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.
NCT07073820
The purpose of this study is to learn about the long-term safety, tolerability and effects of the study medicine (PF-07868489) for the possible treatment of PAH. PAH is a condition in which there is high blood pressure in the arteries that carry blood from the heart to the lungs. This high pressure makes it harder for the heart to pump blood through those lungs, potentially damaging the right side of the heart. This is an open-label study. Which means that both the healthcare providers and the study participants are aware of the medicine being given. This study is also an extension study with study medicine (PF-07868489). An extension study allows patients from an earlier clinical study (also called as qualifying study) to continue participating to assess long-term benefits and safety of the medicine.
NCT07480265
This prospective single-center observational study aims to evaluate the relationship between elevated plasma homocysteine levels and early echocardiographic abnormalities in patients with newly diagnosed essential hypertension. Adult patients diagnosed with essential hypertension within the previous 6 months will undergo clinical assessment, ambulatory blood pressure monitoring, electrocardiography, laboratory testing, and comprehensive transthoracic echocardiography including diastolic function assessment and strain analysis when image quality is adequate. Participants will be classified according to plasma homocysteine level using, and patients with elevated and normal homocysteine levels will be compared with respect to diastolic dysfunction and left ventricular and left atrial global longitudinal strain parameters. Clinical, laboratory, and echocardiographic data will also be used to develop a machine-learning based model for prediction of H-type hypertension.
NCT06137742
The purpose of the study is to learn how the study medicine called PF-07868489 is tolerated and acts in healthy adult people and people with pulmonary arterial hypertension (PAH). Part A: An investigator- and participant-blind, sponsor-open, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics (PK) of PF-07868489 in healthy adult participants. Part B: A 24-week, randomized, double blind, placebo-controlled study to assess the safety, tolerability, PK, and pharmacodynamics (PD) of PF-07868489 in adult participants with PAH.
NCT05131074
This is a clinical study to improve the regularity of medication intake for high blood pressure. Adult women and men who are over 50 years old, who have received a prescription drug for high blood pressure from MediService, and who have to take at least 4 tablets per day (of which at least 1 dose of medication per day is for high blood pressure) can participate in this study. The investigators intend to examine whether Collabree, a mobile phone application, is effective in supporting patients with hypertension to more successfully following their therapy plan in order to improve the regularity of medication intake. The study includes a 90-day intervention phase and a 90-day follow-up. The study does not require any therapy adjustments and no visits to a study center are necessary. The participants conduct the study independently at home. Participants will also fill out questionnaires. Participants are randomly assigned to one of 3 groups in a ratio of 1: 1: 1. Two of these groups will receive the Collabree mobile phone application.
NCT06876233
The goal of this clinical trial is to determine the effectiveness of a novel mobile health-based habit formation intervention for increasing and maintaining adherence to anti-hypertensive (AH) medication among people living with hypertension and indicate medication nonadherence. The main questions it aims to answer are: * Can daily incentives for AH pill taking increase and maintain AH medication adherence, control blood pressure, and reduce healthcare utilization and costs? * Can daily incentives for AH pill taking, combined with action planning (e.g., "After I drink my morning coffee, I will take my medication.") increase and maintain medication adherence, control blood pressure, and reduce healthcare utilization and costs? * What aspects of daily incentives and/or action planning do participants find most helpful or effective for AH medication adherence? * What barriers exist for participants who receive daily incentives and/or action planning? Researchers will compare three study groups: those who only receive daily incentives for the AH pill taking, those who receive daily incentives for AH pill taking combined with action planning, and a control group (who do not receive daily incentives for AH pill taking or action planning). By comparing these three groups, the researchers will be able to determine the effectiveness of the daily incentives with or without action planning for promoting long-term AH medication adherence, reduce healthcare costs, and improve blood pressure. Participants will: * Complete 5 online surveys over the course of 2 years (baseline, month 4, month 8, month 12, month 24). * Submit blood pressure reading for 7 consecutive days after each survey timepoint. * Submit photo evidence of their AH pill taking for 4 months (intervention groups only). The highest- and lowest-performing participants in each intervention group will also be invited to complete a 30-minute interview to identify additional factors that contributed to either successful or unsuccessful completion of the intervention.
NCT07298694
This study aims to evaluate whether modifying the EPIC preference list to display combination blood pressure (BP) medications at the top and/or adding "(PREFERRED)" to the beginning of the medication listing increases prescribing of these medications. Combination BP medications are aligned with value-based care guidelines and may improve patient adherence and reduce pill burden. Currently, these medications may be under-prescribed in part due to their low visibility in the EPIC prescribing interface.
NCT02055209
Our objective is to develop a community-based cohort and novel genomic science resource for defining the biological significance of ancestry-related genomic variation in African-Americans within the GENE-FORECAST :GENomics, Environmental FactORs and the Social DEterminants of Cardiovascular Disease in African Americans STudy. AIM I. examine the associations between common or ancestry-related DNA variants and CVD risk factors (e.g. hypertension) and phenotypes (e.g. coronary artery calcification) in African-Americans (AA).AIM II. To examine the associations between health behaviors or social-environmental factors and CVD risk factors and phenotypes in AA.The study is designed to create a cohort amenable to nested case-control analyses based on a community-based sampling frame with a target size of approximately 1800 self-identified, US -born, African-American (AA) men and women (ages 21-65) to be recruited over the next 5-6 years from the metropolitan Washington DC, Montgomery County (MC) and Prince George s County (PG) areas to be recruited to the NIH Clinical Center. The initial participant recruitment two approaches: 1) a random-digit telephone screening survey targeting study-eligible AA that will be consented and invited to an evaluation visit in the NIH Clinical Center which we contracted with a well-established survey group (Southern Research Group \[SRG\]); and 2) a community outreach effort to recruit participants into the Clinical Center by leveraging marketing and the engagement of community-based leaders, organizations and faith-based institutions in the area. this approach will yield a sample with normal individuals as well as a high proportion of AA with CVD risk factors such as obesity and hypertension that predispose to the eventual clinical signs and symptoms of CVD (e.g. heart attack and stroke). it is anticipated that the prevalence of clinically manifest CVD (history of angina, heart attack or stroke) will be less than 10-15% of the sample. All will medical evaluation (e.g. anthropometrics, blood pressure), laboratory tests (e.g. lipid levels, kidney function), social determinants profiles (e.g. socioeconomic status (SES), perceived stress, discrimination, depression, perceived neighborhood characteristics), blood/urine collection for deep-sequencing based omic analyses (e.g. whole exome sequencing, and RNA-Seq), as well as testing for pre-clinical , biomarkers of the pathobiological processes of CVD or CVD phenotypes (e.g. coronary artery calcification, microalbuminuria, leukocyte telomeres, or vascular dysfunction). It is anticipated that these deep sequencing efforts will yield novel ancestry-related DNA variants associated with the CVD phenotypes; yet with unclear biological significance in elucidating racial disparities in CVD. Accordingly, our protocol also includes a Genotype-to-Phenotype (G2P) component that re- contacts subsets of the cohort based on their genotype (e.g. APOL1 chronic kidney disease risk alleles) for a call-back visit for more in-depth phenotyping and characterization of the potential effect of the DNA variant of interest on human systems biology. In some cases family members of the proband may also be invited to participate in these G2P studies to further characterize the biological significance of these putative functional DNA variants of interest. The primary outcome variables involve well established CVD phenotypes: 1) CVD risk factors (e.g. hypertension, dyslipidemia), 2) markers of pre-clinical CVD (i.e. coronary artery calcification, coronary plaque burden by cardiac CT angiography (CTA), carotid plaque burden by 3D ultrasound, vascular dysfunction, microalbuminuria, C-reactive protein, Vitamin D levels). The protocol will assess exposures associated with CVD and relevant covariates including: 1) social determinants (e.g. socioeconomic status (SES), perceived stress, discrimination, and depression); 2) environmental factors such as neighborhood characteristics (geospatial features of healthy lifestyles \[e.g. walkability\]) and 3) behavioral factors (e.g. diet, physical activity). The G2P callback visit protocol will involve additional measures of in-depth phenotyping that include: 1) peripheral immune cell phenotyping (e.g. T-cell, monocyte subsets); 2) blood/immune cell RNAseq; 3) iPSC cell line generation (endothelial; vascular smooth muscle cells) and analysis of cardiovascular cell systems biology; 4) HDL proteome analysis, 5) FDG PET/CT and/or PET/MRI scan (vascular inflammation) 6) echocardiography, 7) bisulfite sequencing for identifying sites of DNA methylation, and 8) chromatin immunoprecipitation followed by sequencing (Chip-Seq) for identifying sites of histone modification. It is anticipated that this multi-level, multi-dimensional analysis of genomic and phenotypic characteristics of AA will advance our understanding of the bio-social determinants of the intragroup variance and the increased overall burde...
NCT06062394
To leverage access to patients across the primary care network, EPIC tools for identifying eligible patients, and the Way to Health platform to launch and enroll a program that will be evaluated in a clinical trial that is focused on changing patient behavior and powered to detect differences in improving blood pressure and cholesterol over 6 months for Penn Medicine patients in West/Southwest Philadelphia and Lancaster.
NCT07214376
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.
NCT06098092
The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch
NCT05885997
The goal of this research is to determine whether a theory-informed implementation strategy is successful at increasing the uptake of a supported home blood pressure monitoring (HBPM) program as well as to determine the effectiveness of this evidence-based practice when implemented across multiple practices serving a diverse patient population.
NCT06899815
F230 is a new Class 1 chemical drug jointly developed by Beijing Contini Pharmaceutical Co., Ltd. for the treatment of pulmonary hypertension (Notification number: 2024LP01242, 2024LP01243). The in vitro activity and in vivo toxicology tests of F230, the lead compound for the treatment of PAH developed by Beijing Contini Pharmaceutical Co., LTD., showed that F230 had the same in vitro activity as the endothelin antagonist on the market. The pharmacodynamics of F230 in rats with nephrogenic hypertension induced by Sunitinib showed that F230 could reduce proteinuria and improve renal index.It is expected to bring higher treatment and survival benefits to the corresponding patients. According to the spirit of NMPA new drug approval, on the basis of the completion of preclinical studies of this drug, the safety, tolerability and pharmacokinetic characteristics of single administration and multiple administration of this drug in healthy volunteers should be investigated first, and the influence of food on the pharmacokinetic characteristics of F230 in humans should be investigated, so as to recommend a safe and effective administration regimen for phase II clinical trials.
NCT07459972
This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.
NCT07464184
Background and Rationale: Sleep-disordered breathing and nocturnal hypoxemia are highly prevalent in patients with precapillary pulmonary hypertension (PH), and current guidelines recommend systematic sleep assessment in this population. In obstructive sleep apnea, nocturnal hypoxic burden-defined as the area under the SpO₂ desaturation curve associated with respiratory events (%.min/h)-has demonstrated strong prognostic value for cardiovascular morbidity and mortality. However, its role in precapillary PH has not yet been investigated. Evaluating hypoxic burden in this population may refine indications and therapeutic targets for nocturnal oxygen therapy. In addition, pulmonary hypertension is characterized by autonomic nervous system (ANS) dysfunction, including increased sympathetic tone, reduced heart rate variability (HRV), and a higher incidence of cardiac arrhythmias, all associated with worse prognosis. The reduction in HRV is particularly deleterious when occurring during restorative slow-wave sleep (N3), a phase marked by predominant parasympathetic activity essential for cardiovascular recovery and homeostasis. A better understanding of the interaction between nocturnal hypoxemia and ANS modulation may provide new prognostic markers and potential therapeutic targets in PH. Objectives: 1. To describe the evolution of nocturnal hypoxic burden over time in patients with precapillary pulmonary hypertension (at baseline, 12 months, and 24 months). 2. To describe the longitudinal evolution of HRV parameters (RMSSD, LF/HF ratio, HF) at baseline, 12 months, and 24 months. 3. To evaluate cross-sectional correlations (at baseline, M12, and M24) between HRV parameters, hypoxic burden, oxygen desaturation, apnea-hypopnea index (AHI), and clinical status. 4. To evaluate longitudinal correlations between changes in HRV parameters, hypoxic burden, desaturation, AHI, and clinical status between baseline and M12, and between baseline and M24. 5. To assess the 2-year prognostic value of HRV parameters and hypoxic burden for adverse clinical outcomes. Study Design and Population: This is a prospective, single-center observational cohort study conducted at the Pulmonary Hypertension Referral Center of Rouen University Hospital. The cohort design allows longitudinal assessment of HRV, hypoxic burden, and clinical status, enabling both cross-sectional and longitudinal correlation analyses, as well as prognostic evaluation. A total of 60 adult patients (≥18 years) with precapillary pulmonary hypertension confirmed by right heart catheterization and requiring pulmonary arterial vasodilator therapy will be included. Participants will undergo full overnight polysomnography (PSG) at: * Baseline (inclusion) * 12 months (M12) * 24 months (M24) For incident cases, baseline PSG will be performed prior to initiation of vasodilator therapy. All patients will continue to receive standard-of-care management according to current European guidelines for pulmonary hypertension. Descriptive analyses and cross-sectional correlations will pool repeated measures (excluding incident baseline values for generalization to prevalent cases). Intra-subject correlation will be accounted for using bootstrap methods. Longitudinal analyses will assess changes over time and prognostic associations. The prognostic value of HRV and hypoxic burden will be evaluated over a 2-year follow-up period. This study explores an original dimension of precapillary pulmonary hypertension pathophysiology by investigating the interaction between nocturnal oxygenation, autonomic dysfunction, and clinical evolution. Identification of hypoxic burden and HRV as prognostic markers may contribute to improved risk astratification and therapeutic optimization in this high-risk population.