Clinical trials on Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension: An Overview

Pulmonary Arterial Hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure in the arteries that go from the heart to the lungs. Unlike regular hypertension, which affects the systemic blood vessels throughout the body, PAH specifically targets the pulmonary arteries. This condition can lead to several complications, including right heart failure, due to the increased workload on the right ventricle to pump blood through narrowed or obstructed pulmonary arteries.

The symptoms of PAH are often non-specific and can include shortness of breath (dyspnea), fatigue, dizziness, and chest pain. These symptoms typically worsen with exercise or physical activity. Because these symptoms can be associated with many other conditions, PAH can be challenging to diagnose early. Diagnosis often involves a combination of history taking, physical examination, and specialized tests, including echocardiography, right heart catheterization, and various imaging studies.

Treatment and Management

Treatment for PAH aims to manage symptoms and slow the progression of the disease. While there is currently no cure for PAH, advancements in treatment have significantly improved the quality of life and survival rates for many patients. Treatment options include medications such as vasodilators, endothelin receptor antagonists, phosphodiesterase inhibitors, and prostacyclin analogs. In more severe cases, oxygen therapy, lung transplantation, or atrial septostomy may be considered. Lifestyle modifications and supportive care are also crucial components of managing PAH, helping patients to cope with the physical and emotional challenges of the disease.

  • CT-EU-00022900

    Assessing imatinib inhalation therapy for pulmonary arterial hypertension

    This clinical study aims to evaluate the safety and efficacy of an inhaled treatment called imatinib (AV-101) for patients with Pulmonary Arterial Hypertension (PAH). The trial is divided into two parts: Phase 2b and Phase 3. In Phase 2b, researchers will test three doses of AV-101 to identify the optimal dose for Phase 3. They will check this by measuring the resistance of the lung vessels — less resistance means the medicine is working. In the following Phase 3, the primary outcome will be the change in the 6-minute walk distance after 24 weeks of treatment compared to a placebo. Participants must be between 18 and 75 years old, have a diagnosis of PAH, and meet specific criteria regarding their disease severity and concomitant therapy.

    • Imatinib/AV-101
  • Testing a new inhaled drug for pulmonary arterial hypertension

    This study focuses on the efficiency and safety of a new inhaled drug – MK-5475 – for patients suffering from Pulmonary Arterial Hypertension (PAH). The study is divided into two parts: phase 2 and phase 3. In phase 2, the researchers will compare three different doses of MK-5475 with a placebo over a base period of 12 weeks. The goal is to find out if any of the doses can decrease the patient’s pulmonary vascular resistance (PVR), which is the resistance that the heart must overcome to pump blood through the lungs. In Phase 3 of the study, the best performing dose from Phase 2 will be used to confirm its long-term effectiveness, safety, and tolerability over a 12-week base period with a follow-up period of up to five years. The focus is to see if this dose is better than a placebo in improving the patient’s walking distance over 6 minutes. The study aims at improving the quality of life and physical health of PAH patients with the help of the new drug.

    • MK-5475
  • Testing sotatercept with regular treatment in severe pulmonary arterial hypertension patients

    This investigation seeks to assess the effect of a new drug named Sotatercept on people who are suffering from a serious lung disease called ‘Pulmonary Arterial Hypertension’ (PAH). The trial is intended for individuals with high-risk PAH who are facing significant danger of death. The main goal is to find out if incorporating Sotatercept into the standard treatment can improve outcomes and potentially enhance the chances of survival. Participants who enroll will receive either Sotatercept in addition to their current medication or a placebo alongside their regular treatment.

    • Sotatercept
  • Testing macitentan effects on kids’ lung pressure illness

    This study is looking to find out if a medicine named Macitentan can help slow down the progression of a lung condition known as Pulmonary Arterial Hypertension (PAH) in kids. The study will be done in several places and everyone will know what treatment they receive. The researchers will compare the results of kids taking Macitentan to those receiving the usual care for PAH. They will check how the drug reacts in the body and how safe it is. The researchers will also see if it improves health outcomes like, need for a lung transplant or other treatments, and hospitalization.

    • macitentan
  • Testing ralinepag in the treatment of patients with pulmonary arterial hypertension

    This research study, will test the effectiveness and safety of a drug called Ralinepag in treating a heart and lung condition called Pulmonary Arterial Hypertension (PAH). Participants will be randomly sorted into two groups. One group will receive Ralinepag. The other group will receive a placebo, which doesn’t have any active medication. Everyone in the study will also continue with their usual treatment for PAH. The aim is to find out how long participants can go without their PAH getting worse after receiving Ralinepag or the placebo. If patients wish, after the study, they can take part in an additional follow-up study. If they choose not to take part in this follow-up, they will stop taking the study drug but will still be checked on for a while longer. The researchers will also consider how the treatment affects quality of life and whether it causes any side effects.

    • Ralinepag
  • Testing inhaled imatinib for pulmonary arterial hypertension

    This study is about a new medicine called imatinib (AV-101) which you breathe in as a dry powder. It’s for people who have a health problem called Pulmonary Arterial Hypertension (PAH) – when blood pressure is too high in the arteries that go from the heart to the lungs. The imatinib study will go through two stages. In the first stage, the researchers will try three different amounts of the medicine to find the best one. It will be based on how much it can reduce the resistance in the blood flow in the lungs. In the second stage, they it will be seen how far patients can walk in 6 minutes after taking the medicine for 24 weeks. The study also uses scoring systems to measure how much risk or symptoms a patient has. A higher score means more risk or symptoms.

    • imatinib/ AV-101
  • Children’s study on sotatercept for pulmonary arterial hypertension

    This study evaluates the safety and tolerability of sotatercept in children aged 1 to 17 years with Pulmonary Arterial Hypertension (PAH). Over 24 weeks, 42 participants will receive sotatercept to understand how the body processes the drug and its effects. The study will monitor various health parameters, including blood pressure, heart function, and quality of life. Key outcomes include measuring serum concentrations of sotatercept, changes in heart and lung function, and overall well-being. This trial aims to improve treatment for children with PAH.

    • Sotatercept
  • Long-term study on sotatercept effects in pulmonary arterial hypertension treatment

    This study aims to deepen our understanding and assess the effects of the drug sotatercept in treating Pulmonary Arterial Hypertension (PAH), a lung disease characterized by elevated blood pressure in the lungs. Building on promising results from a previous study where sotatercept demonstrated improvements in heart function and physical ability among patients, the current research seeks to validate these findings. The study is anticipated to span approximately 50 months, during which regular evaluations will be conducted to assess both the safety and beneficial effects of sotatercept. Importantly, this study involves patients who have previously undergone treatments with sotatercept, allowing researchers to gather insights into the longer-term effects and sustained benefits of the drug.

    • Sotatercept
  • Evaluating the efficacy of macitentan in the treatment of high pulmonary artery blood pressure

    This study is checking if a 75 mg dose of a medicine called Macitentan can do a better job for patients with a lung condition called Pulmonary Arterial Hypertension (PAH) compared to a 10 mg dose. The main goal is to see if the 75 mg dose can better delay the patient’s first major health event related to PAH. Major events include things like unplanned hospital stays related to PAH, or their PAH getting worse. The researchers will check if patients’ PAH gets worse by looking at things like their physical exercise ability and signs of heart failure. The study also looks at how patients’ symptoms change from day to day.

    • macitentan
  • Sotatercept treatment study for new Pulmonary Hypertension patients

    This study is an important test where doctors are looking at how a drug called Sotatercept can help people struggling with Pulmonary Arterial Hypertension (or PAH for short). The goal is to see whether this drug can delay or prevent the condition from getting worse. PAH makes it really hard for patients to breathe because it affects lungs and heart. The testing process is being done in a fair and careful way. Half of the patients will get the drug, and the others will get a ‘placebo’ which doesnt contain any medicine. The doctors will look at the effect on patients over time. The study is looking specifically at patients who were recently diagnosed with PAH and are at risk for the disease to get worse.

    • Sotatercept
  • Testing Treprostinil Palmitil inhalation powder for pulmonary arterial pressure

    This trial is about a new drug called Treprostinil Palmitil Inhalation Powder (TPIP). TPIP is tested on people who have a condition where the blood pressure in the lungs is too high. This condition is called Pulmonary Arterial Hypertension. The objective of this study is to ascertain the effectiveness and safety of TPIP, and to examine its pharmacokinetics, i.e., how it moves within the body. The trial is set up in such a way that some people will get TPIP, while others receive a placebo. The primary focus is on determining whether TPIP can effectively reduce resistance to blood flow within the lungs, constituting a key aspect of the study’s goals.

    • Treprostinil Palmitil