Pulmonary Arterial Hypertension (PAH)

Researchers are studying the long-term effects of reducing household air pollution (HAP) from biomass fuel use on heart, lung, and immune health among women and children in semi-rural Bangladesh. The study evaluates whether a mobile phone-based behavioral change communication (mHealth BCC) intervention can increase the adoption and exclusive use of cleaner cooking fuel, Liquid Petroleum Gas (LPG). This research also investigates how lowering pollution exposure might influence immune responses to vaccines and subclinical cardiovascular and pulmonary changes. The study is a large household-level randomized controlled trial comparing two groups: one receiving the mHealth BCC intervention encouraging exclusive LPG use and a control group receiving no such intervention. Researchers will monitor personal and area levels of air pollutants like PM2.5 and black carbon before and after intervention, alongside detailed assessments including spirometry, chest X-rays, high-resolution CT scans, blood pressure, EKG, metabolic markers such as HbA1c and lipid profiles, and immune cell function. The intervention messages are delivered via mobile phone with frequency tailored to participant responses. Participants will be followed over two years with repeated measurements to assess pollutant exposure and health effects. Evaluations include lung function tests, imaging, cardiovascular markers, metabolic blood tests, and immune function assays. The study aims to provide insights into the health benefits of sustained LPG use and improved air quality. Total participation spans pre-intervention assessments through two years of follow-up, with ongoing monitoring of pollution exposure and health outcomes.

Researchers are evaluating the use of 129Xe MRI/MRS 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 MRI/MRS 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 MRI/MRS 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 investigating new treatments for Pulmonary Arterial Hypertension (PAH), a condition where the blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and making it difficult for the heart to work properly. PAH can lead to breathing difficulties and reduced activity levels. While current treatments help manage symptoms, they do not stop the disease from progressing. Sotatercept is a study medicine designed to target specific proteins involved in PAH, and this long-term follow-up study aims to assess its safety and tolerability when used alongside standard PAH treatments over an extended period. Participants who have completed previous sotatercept PAH studies may join this open-label follow-up study. Those from blinded studies will start sotatercept at 0.3 mg/kg by subcutaneous injection every three weeks and may increase to 0.7 mg/kg. Participants from unblinded studies will continue their current dose and may also increase to 0.7 mg/kg. The study focuses on monitoring sotatercept use combined with background PAH therapy to observe long-term effects. Throughout the study, participants will undergo regular assessments including tracking adverse events, laboratory tests for blood and chemistry markers, body weight, blood pressure, and electrocardiograms up to approximately 7 years. Additional measurements include walking distance tests, heart function markers, and risk scores related to PAH. Safety monitoring and tolerance to the medication will be closely observed over time to better understand sotatercept’s long-term impact in managing PAH.

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-ECG's effectiveness in detecting pulmonary hypertension early.

Researchers are evaluating IMC-003 treatment in patients with pulmonary arterial hypertension (PAH) who are already receiving background therapy. This Phase Ib/IIa clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of IMC-003 in this patient group. The study is randomized, double-blind, and placebo-controlled to provide reliable results about the treatment's impact on PAH. Participants will receive either IMC-003 injections or placebo injections eight times, once every three weeks, while continuing their stable background therapy for PAH. This dose-escalation study compares the effects of IMC-003 with placebo to help identify the recommended dose for future studies. The treatment period lasts 24 weeks. Throughout the study, participants will undergo evaluations including hemodynamic measurements like pulmonary vascular resistance, safety monitoring, and functional assessments such as the six-minute walk distance. The primary focus is on safety and tolerability by Day 169, with secondary measures assessing changes in pulmonary vascular resistance. The entire study spans several months, with careful monitoring to understand the treatment's effects and side effects.

Researchers are evaluating the safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) combined with antibiotic preconditioning and fiber supplementation in adults with pulmonary arterial hypertension (PAH). This pilot clinical trial will help guide future studies of MTT as a potential treatment for PAH by comparing it to placebo treatment. The study is randomized, placebo-controlled, and double-blind, involving 24 patients with PAH. Participants will be assigned to one of three groups: MTT with antibiotic preconditioning plus fiber supplementation, MTT with antibiotic preconditioning plus placebo supplementation, or placebo plus placebo supplementation. MTT is given as capsules containing freeze-dried intestinal microbiota from healthy donors, and fiber supplements will be 10 to 14 grams taken orally. Follow-up visits occur at weeks 1, 2, 4, 12, and 24. Stool and blood samples are collected at specified times, and patients undergo echocardiograms, six-minute walk tests, and quality of life questionnaires at baseline and week 12. During the study, patients provide stool samples at baseline, week 1, week 4, and week 12, and blood samples at baseline, week 4, and week 12. They complete functional assessments such as echocardiograms and six-minute walk tests and answer quality of life questionnaires. The main outcome is donor microbiota engraftment at week 12. Safety, feasibility, inflammatory markers, and right ventricular function are also evaluated. The total participation duration includes follow-up to week 24, with monitoring by telephone, in-person, email, or video visits.

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.

Researchers are conducting a 20-week, Phase 1, single-center, open-label study to evaluate the safety and tolerability of daily oral artesunate in adults with pulmonary arterial hypertension (PAH). This study focuses on patients who continue to experience symptoms despite treatment with multiple standard therapies. The goal is to understand how well artesunate is tolerated and to monitor any related side effects in this patient group. Participants will receive artesunate capsules taken three times daily. The study uses a dose escalation design, starting with 20 mg three times daily for 4 weeks, then increasing to 40 mg three times daily for another 4 weeks, followed by 60 mg three times daily for a final 4 weeks. After the treatment periods, there is a 2-week follow-up washout phase to observe any lasting effects after stopping the medication. Throughout the 14-week study period, including up to 4 weeks of screening, participants will be closely monitored for treatment-related adverse events and serious adverse events. Researchers will assess safety by recording any side effects during and after the treatment phase. The total involvement includes screening, treatment, and a follow-up period to ensure participant safety and collect important data about tolerability.