Pulmonary Arterial Hypertension (PAH)

This study evaluates whether a mobile phone-based mHealth Behavioural Change Communication BCC educational intervention can improve the adoption and exclusive use of Liquid Petroleum Gas LPG for cooking among households in semi-rural Bangladesh. Household air pollutants HAP from biomass fuels such as wood, agricultural residue, and cow dung expose almost 3 billion people worldwide, including 89% of people in Bangladesh. In the earlier GEOHealth study, 24 months of LPG use reduced personal PM2.5 exposure by about 58.2% and produced changes in innate immune and inflammatory responses, while chronic cardio-pulmonary markers remained relatively stable. More than 70% of households continued using LPG after the earlier study, although not exclusively. The investigators will conduct a large household-level randomized controlled trial using an mHealth-based educational intervention and will continue following the cohort. The study will examine the long-term effects of HAP reduction on subclinical measures of cardiovascular and pulmonary dysfunction, innate and inflammatory immune function, and antibody response to vaccines. Personal 24-hour and area-wise 5-day exposure to PM2.5 and black carbon will be repeatedly assessed before and after the intervention. Lung function and lung pathology will be assessed using spirometry, Chest X-ray, and high-resolution computed tomography of the chest. Cardiovascular measures will include blood pressure and EKG, while metabolic dysfunction will be assessed using HbA1c and fasting lipid profile. Immune function will be evaluated through immune cell phenotyping, functional cytotoxic killer cells, and oxidative stress of lymphocytes.

Researchers are evaluating the use of 129Xe MRIMRS biomarker signatures to non-invasively monitor changes in the lungs of patients with pulmonary arterial hypertension PAH who are treated with sotatercept. The study aims to predict short- and long-term responses to sotatercept and improve assessment of treatment outcomes compared to current standard methods. PAH involves blood vessel remodeling in the lungs that leads to heart failure and reduced lung function, and sotatercept is being studied for its potential to reverse these changes. Participants with PAH receiving sotatercept as part of their clinical care will undergo 129Xe MRIMRS scans at baseline, 3 months, and 12 months. These scans measure ventilation defects, blood volume in lung capillaries, lung wall thickness and inflammation, and heart-related oscillations. Alongside the imaging, standard assessments such as laboratory tests, heart ultrasound, NTproBNP blood tests, and a 6-minute walk test will be performed at each visit. During the study, participants will have multiple visits to complete imaging, lab work, and functional tests to monitor lung and heart function. Researchers will track changes in specific MRIMRS biomarkers and cardiogenic oscillation amplitudes over time to evaluate treatment effects. The study includes safety monitoring and will last until at least 12 months after starting sotatercept treatment.

Researchers are studying pulmonary arterial hypertension PAH, including its common subtypes idiopathic PAH IPAH and connective tissue disease-associated PAH PAH-CTD. The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance 6MWD are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.

Researchers are studying how blood flow to muscles is controlled and how this changes with age and certain diseases such as chronic obstructive pulmonary disease COPD, sepsis, pulmonary hypertension, and cardiovascular disease. The study focuses on four key pathways that affect blood vessel constriction and dilation Angiotensin-II, Endothelin-1, Nitric Oxide, and oxidative stress. The goal is to better understand how these pathways contribute to reduced blood flow during exercise and whether these changes can be improved. Participants will receive various treatments including exercise tests and drugs that affect blood vessel function, such as Nitric Oxide blockers, antioxidants, receptor antagonists, and other vasoactive agents. These treatments will be given through catheter placements for measurements and infusions. Different groups include healthy young adults, older adults, and patients with conditions like COPD, pulmonary arterial hypertension, heart failure, and hypertension. The study will also evaluate effects before and after exercise training. During the study, participants will undergo tests such as maximum exercise capacity, measurements of blood flow, blood pressure, muscle metabolism, and muscle fatigue using advanced imaging techniques like Nuclear Magnetic Resonance NMR. Researchers will monitor changes in limb blood flow and other outcomes at baseline and one hour after treatments. The study aims to provide detailed insight into how vascular function changes with age and disease and how it responds to various interventions over time.

Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Pulmonary hypertension is a condition that is often underdiagnosed due to its many causes. Researchers are evaluating an artificial intelligence-enabled electrocardiogram AI-ECG to screen for elevated pulmonary arterial pressure PAP in patients at high risk. This approach aims to identify pulmonary hypertension earlier, leading to further testing and potentially improving heart-related outcomes. The study is a randomized controlled trial sponsored by the National Defense Medical Center, Taiwan. Participants are divided into two groups. One group is screened with the AI-ECG system, and if they are identified as high-risk for pulmonary hypertension, they receive an echocardiogram to confirm the diagnosis and help guide treatment. The other group undergoes AI-ECG screening but continues with usual clinical care without additional echocardiography. The study uses this comparison to assess the value of AI-ECG-guided screening. During the study, participants will have ECGs and may have echocardiograms depending on their group and risk. Researchers will monitor heart measurements like pulmonary arterial pressure, left atrial size, right ventricular size, and left ventricular function within 90 days after starting the study. The main focus is on whether pulmonary arterial pressure exceeds 50 mmHg. The study lasts at least three months from randomization, with detailed heart imaging and function assessments to understand the AI-ECGs effectiveness in detecting pulmonary hypertension early.

Researchers are conducting a Phase IbIIa clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of IMC-003 injection in adults with pulmonary arterial hypertension PAH who are already receiving background therapy. The trial focuses on patients with WHO Group 1 PAH, including several subtypes such as idiopathic, heritable, and drug-induced PAH. Participants must have symptomatic PAH with specific functional classifications and hemodynamic criteria confirmed by right heart catheterization. Participants will be randomly assigned to receive either IMC-003 or a placebo, injected eight times every three weeks while continuing their stable background PAH treatment. Background therapy includes approved drugs such as endothelin receptor antagonists, PDE-5 inhibitors, sGC stimulators, and prostacyclin analogs. The study is double-blinded and parallel in design, and treatment will last for 24 weeks in both phases of the trial. During the study, participants will undergo various assessments including heart MRI, 6-minute walk distance tests, and blood tests measuring NT-proBNP and other hemodynamic parameters. Researchers will monitor safety, disease progression, and treatment effects throughout the 24-week treatment period. The study also includes ongoing evaluation of symptoms, functional classification, and laboratory markers to understand the impact of IMC-003 in this patient population.

Researchers are evaluating microbiota transplant therapy MTT combined with antibiotic preconditioning and fiber supplementation in adults with pulmonary arterial hypertension PAH. This pilot clinical trial aims to assess the initial safety, feasibility, and how the body processes this treatment compared to placebo. The study will help guide future research on using MTT as a potential treatment for PAH. Participants are randomly assigned to one of three groups MTT with antibiotic preconditioning plus fiber supplementation, MTT with antibiotic preconditioning plus placebo supplementation, or placebo with placebo supplementation. MTT is given as capsules containing freeze-dried intestinal microbiota from healthy donors, and fiber supplementation is an oral dose of 10-14 grams. Treatment and follow-up visits are scheduled at weeks 1, 2, 4, 12, and 24. During the study, participants will provide stool and blood samples at multiple time points to monitor changes. They will also undergo an echocardiogram, six-minute walk test, and quality of life questionnaire at the start and at week 12. The research team will measure donor microbiota engraftment, safety, feasibility, inflammatory markers, and heart function. The entire participation may last up to 24 weeks, including various assessments and monitoring.

Researchers are studying the effects of living at high altitude during pregnancy by following two groups of healthy pregnant women one group residing at elevations above 3,500 meters and another residing at sea level. The study aims to understand how chronic low oxygen levels at high altitudes affect heart function, especially the right side of the heart, fetal growth, and the role of nitric oxide in pregnancy complications related to blood vessel and heart function. The study involves detailed heart ultrasound examinations to assess right heart anatomy and function, including measurements of pulmonary artery pressure and right ventricular performance. Researchers will also track fetal growth before and after birth, examine placental characteristics, and measure nitric oxide-related substances in maternal blood, umbilical cord blood, and placental tissue. These assessments will be correlated with oxygen levels and altitude exposure. Flow-mediated dilation tests will be performed in the high altitude group to evaluate blood vessel function. Participants will be monitored through late pregnancy around 35 weeks and into the postpartum period about 6 weeks after delivery. Researchers will collect data on heart and fetal measurements, nitric oxide levels, and birth weight. This comprehensive monitoring aims to clarify how high altitude impacts cardiovascular health and fetal development during and after pregnancy, with ongoing follow-up until postpartum.

This clinical trial is studying patients with combined pre- and post-capillary pulmonary hypertension CpcPH linked to left heart disease LHD. It aims to evaluate the safety and effectiveness of a new device called the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System, compared to standard medical therapy. The study includes patients with chronic heart failure who are stable and already receiving the best available medical treatments for left heart failure. Participants will be randomly assigned to one of two groups the intervention group will receive pulmonary artery denervation PADN using the Enhancor System plus guideline-directed medical therapy GDMT, while the control group will undergo a placebo procedure plus GDMT. Before randomization, some operators may perform up to two roll-in PADN procedures to gain experience. Participants will be followed for 3 years, with clinical assessments at 1, 6, 12, 24, and 36 months. Control subjects who experience a primary efficacy endpoint event may cross over to receive PADN after 24 months if eligible. During the study, participants will undergo various assessments including heart function tests, walking distance tests, biomarker blood tests NT-proBNP, and quality of life questionnaires Kansas City Cardiomyopathy Questionnaire at several time points. Safety will be monitored closely, especially within 30 days after the procedure. Researchers will track heart failure events, hospitalizations, device implantations, heart transplantations, and cardiovascular deaths over the 3 years. Participants are expected to comply with medication and follow-up visits throughout the study.